Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT04752358
Status:
TERMINATED
Last Update Posted:
2024-09-04
First Post:
2021-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'United Kingdom'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@adaptimmune.com', 'phone': '+1 (215) 825-9260', 'title': 'Clinical Trials Management', 'organization': 'Adaptimmune'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events were collected from the start of lymphodepleting chemotherapy until the end of the interventional phase (up to 5 months). Deaths were collected from start of lymphodepletion chemotherapy until the end of the study (up to 7 months).', 'description': 'Serious adverse events were reported for all participants who received ADP-A2M4CD8', 'eventGroups': [{'id': 'EG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Migraine with aura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Cytomegalovirus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}], 'seriousEvents': [{'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Oesophageal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 25'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR) by Independent Radiological Assessment Committee (IRAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'timeFrame': 'From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion).', 'description': 'Confirmed tumor response (complete response \\[CR\\] or partial response \\[PR\\]) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by IRAC', 'calculatePct': False, 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8. No subject images were assessed by Independent Reviewer due to lack of efficacy observed on Investigator review. Thus, no results are reported.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Participants With Adverse Events (AEs) Including Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'AESI - cytokine release syndrome', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'AESI- ICANS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AESI- Prolonged cytopenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of lymphodepleting chemotherapy to end of Interventional Phase (up to 5 months)', 'description': 'An AE was defined as any untoward medical occurrence in a subject or clinical study participant temporally associated with the use of the study intervention, whether or not considered related to the study intervention. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants with AEs (including SAEs), SAEs and AESI including cytokine release syndrome, ICANS, and prolonged cytopenia are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) by IRAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'timeFrame': 'From T-cell infusion until first documented confirmed CR or PR', 'description': 'TTR (CR or PR) was defined as the interval between the date of first T-cell infusion and the earliest date of first documented confirmed CR or confirmed PR.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8 and had a confirmed CR or PR. No subjects had a confirmed CR or PR. Thus, no results are reported.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR) by IRAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'timeFrame': 'From initial date of first confirmed response (CR or PR) until PD or death', 'description': 'DoR is defined as duration between the initial date of the confirmed complete or partial response to the date of progressive disease or death, where tumor response and disease progression were assessed by IRAC.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8 and had a confirmed CR or PR. No subjects had a confirmed CR or PR. Thus, no results are reported.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response (BOR) by IRAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'timeFrame': 'From T-cell infusion until disease progression', 'description': 'BOR is the best response recorded from the start of T-cell infusion until disease progression as assessed by IRAC. Response categories are confirmed CR, confirmed PR, stable disease (SD) and confirmed progressive disease (PD).', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8. No subject images were assessed by Independent Reviewer due to lack of efficacy observed on Investigator review. Thus, no results are reported.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) by IRAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'timeFrame': 'From T-cell infusion until first documented PD, as assessed by IRAC, or death due to any cause, whichever occurs first', 'description': 'PFS is defined as time from the T-cell infusion to the date of the first documentation of progressive disease (PD) as assessed by IRAC or death due to any cause, whichever occurs first.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8. No subject images were assessed by IRAC due to lack of efficacy observed on Investigator review. Hence, no results are reported.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) by Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion).', 'description': 'Confirmed tumor response (complete response \\[CR\\] or partial response \\[PR\\]) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator Assessment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) by Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'timeFrame': 'From T-cell infusion until first documented confirmed CR or PR', 'description': 'TTR (CR or PR) was defined as the interval between the date of first T-cell infusion and the earliest date of first documented confirmed CR or confirmed PR', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8 and had a confirmed CR or PR. No subjects had a confirmed CR or PR. Thus, TTR was not calculated, and no results are reported.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR) by Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'timeFrame': 'From initial date of first confirmed response (CR or PR) until PD or death', 'description': 'DoR is defined as duration between the initial date of the confirmed complete or partial response to the date of progressive disease or death, where tumor response and disease progression were assessed by Investigator Assessment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8 and had a confirmed CR or PR. No subjects had a confirmed CR or PR. Thus, DoR was not calculated, and no results are reported.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response (BOR) by Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From T-cell infusion until disease progression (Up to 5 months)', 'description': 'BOR is the best response recorded from the start of T-cell infusion until disease progression as assessed by the Investigator. Response categories are confirmed CR, confirmed PR, stable disease (SD) and confirmed progressive disease (PD).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) by Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '14.43', 'groupId': 'OG000', 'lowerLimit': '8.14', 'upperLimit': '20.71'}, {'value': '8.43', 'groupId': 'OG001', 'lowerLimit': '8.43', 'upperLimit': '8.43'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From T-cell infusion until first documented PD, as assessed by Investigator, or death due to any cause, whichever occurs first (up to 5 months)', 'description': 'PFS is defined as the time from the T-cell infusion to the date of the first documentation of progressive disease (PD) as assessed by investigator assessment or death due to any cause, whichever occurs first.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '19.64', 'groupId': 'OG000', 'lowerLimit': '18.57', 'upperLimit': '20.71'}, {'value': '29.71', 'groupId': 'OG001', 'lowerLimit': '29.71', 'upperLimit': '29.71'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From T-cell infusion to death due to any reason (up to 7 months)', 'description': 'OS is defined as the time from the date of first T-cell infusion to the date of death (due to any cause).', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8'}, {'type': 'SECONDARY', 'title': 'Replication Competent Lentivirus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion and a post-infusion sample tested for VSV-G (RCL)'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion and a post-infusion sample tested for VSV-G (RCL)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From T-cell infusion to end study (up to 7 months)', 'description': 'The presence of RCL was assessed by qPCR targeting a segment of the vesicular stomatitis virus glycoprotein (VSV G) coding sequence. 1 participant had at least 1 post-infusion sample tested for RCL.\n\nThe count of participants with RCL post-infusion is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8 and had a post-infusion sample tested for VSV-G'}, {'type': 'SECONDARY', 'title': 'Insertional Oncogenesis (IO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'timeFrame': 'From 1 year post T-cell infusion', 'description': 'Deoxyribonucleic acid (DNA) from participants peripheral blood mononuclear cell (PBMC) samples are subjected to lentiviral vector integration site analysis by next-generation sequencing, thus evaluating both the clonality status of the transduced cell population and the genomic localization of individual integration sites. The outcome measure is the number of participants with integration sites representing more than 5% of all unique sites.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8 and had a sample analyzed for IO. All subjects died prior to 1 year post T-cell infusion, subsequently no samples were obtained or analyzed.'}, {'type': 'SECONDARY', 'title': 'Peak Persistence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '59546.3', 'groupId': 'OG000', 'lowerLimit': '41432.7', 'upperLimit': '77660'}, {'value': '135581.5', 'groupId': 'OG001', 'lowerLimit': '135581.5', 'upperLimit': '135581.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From T-cell infusion to end study (up to 7 months)', 'description': 'Peak persistence of ADP-A2M4CD8 cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).', 'unitOfMeasure': 'copies/microgram DNA', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8'}, {'type': 'SECONDARY', 'title': 'Time to Peak Persistence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'OG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '15'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From T-cell infusion to end study (up to 7 months)', 'description': 'Time from ADP-A2M4CD8 T-cell infusion to peak persistence of cells.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received ADP-A2M4CD8'}, {'type': 'SECONDARY', 'title': 'Concordance of the MAGE A-4 Clinical Trial Assay and in Vitro Diagnostic (IVD) Kit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Screened Participants', 'description': 'All participants who were screened and had slides available for MAGE A4 assay'}], 'timeFrame': 'Screening visit', 'description': 'Concordance of the MAGE A-4 clinical trial assay and in vitro diagnostic (IVD) kit.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to study termination, an IVD kit for companion diagnosis was not developed. Thus, there is no data to report regarding concordance of the MAGE A-4 clinical trial assay and the IVD companion diagnostic kit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'FG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This was a Phase 2 open-label, single treatment, clinical trial of ADP-A2M4CD8 in participants with advanced esophageal or esophagogastric junction cancers', 'preAssignmentDetails': 'All participants were assigned to one treatment (ADP-A2M4CD8)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Esophageal', 'description': 'Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'BG001', 'title': 'Esophagogastric Junction', 'description': 'Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000', 'lowerLimit': '67', 'upperLimit': '69'}, {'value': '72', 'groupId': 'BG001', 'lowerLimit': '72', 'upperLimit': '72'}, {'value': '69', 'groupId': 'BG002', 'lowerLimit': '67', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Eligible participants who received ADP-A2M4CD8 as a single infusion'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-17', 'size': 2156620, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-14T08:44', 'hasProtocol': True}, {'date': '2023-11-23', 'size': 1308882, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-14T08:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Study was terminated due to difficulty recruiting subjects and lack of efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2021-02-08', 'resultsFirstSubmitDate': '2024-05-20', 'studyFirstSubmitQcDate': '2021-02-11', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-09', 'studyFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR) by Independent Radiological Assessment Committee (IRAC)', 'timeFrame': 'From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion).', 'description': 'Confirmed tumor response (complete response \\[CR\\] or partial response \\[PR\\]) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by IRAC'}], 'secondaryOutcomes': [{'measure': 'Number and Percentage of Participants With Adverse Events (AEs) Including Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)', 'timeFrame': 'From start of lymphodepleting chemotherapy to end of Interventional Phase (up to 5 months)', 'description': 'An AE was defined as any untoward medical occurrence in a subject or clinical study participant temporally associated with the use of the study intervention, whether or not considered related to the study intervention. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants with AEs (including SAEs), SAEs and AESI including cytokine release syndrome, ICANS, and prolonged cytopenia are presented.'}, {'measure': 'Time to Response (TTR) by IRAC', 'timeFrame': 'From T-cell infusion until first documented confirmed CR or PR', 'description': 'TTR (CR or PR) was defined as the interval between the date of first T-cell infusion and the earliest date of first documented confirmed CR or confirmed PR.'}, {'measure': 'Duration of Response (DoR) by IRAC', 'timeFrame': 'From initial date of first confirmed response (CR or PR) until PD or death', 'description': 'DoR is defined as duration between the initial date of the confirmed complete or partial response to the date of progressive disease or death, where tumor response and disease progression were assessed by IRAC.'}, {'measure': 'Best Overall Response (BOR) by IRAC', 'timeFrame': 'From T-cell infusion until disease progression', 'description': 'BOR is the best response recorded from the start of T-cell infusion until disease progression as assessed by IRAC. Response categories are confirmed CR, confirmed PR, stable disease (SD) and confirmed progressive disease (PD).'}, {'measure': 'Progression Free Survival (PFS) by IRAC', 'timeFrame': 'From T-cell infusion until first documented PD, as assessed by IRAC, or death due to any cause, whichever occurs first', 'description': 'PFS is defined as time from the T-cell infusion to the date of the first documentation of progressive disease (PD) as assessed by IRAC or death due to any cause, whichever occurs first.'}, {'measure': 'Overall Response Rate (ORR) by Investigator Assessment', 'timeFrame': 'From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion).', 'description': 'Confirmed tumor response (complete response \\[CR\\] or partial response \\[PR\\]) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator Assessment'}, {'measure': 'Time to Response (TTR) by Investigator Assessment', 'timeFrame': 'From T-cell infusion until first documented confirmed CR or PR', 'description': 'TTR (CR or PR) was defined as the interval between the date of first T-cell infusion and the earliest date of first documented confirmed CR or confirmed PR'}, {'measure': 'Duration of Response (DoR) by Investigator Assessment', 'timeFrame': 'From initial date of first confirmed response (CR or PR) until PD or death', 'description': 'DoR is defined as duration between the initial date of the confirmed complete or partial response to the date of progressive disease or death, where tumor response and disease progression were assessed by Investigator Assessment.'}, {'measure': 'Best Overall Response (BOR) by Investigator Assessment', 'timeFrame': 'From T-cell infusion until disease progression (Up to 5 months)', 'description': 'BOR is the best response recorded from the start of T-cell infusion until disease progression as assessed by the Investigator. Response categories are confirmed CR, confirmed PR, stable disease (SD) and confirmed progressive disease (PD).'}, {'measure': 'Progression Free Survival (PFS) by Investigator Assessment', 'timeFrame': 'From T-cell infusion until first documented PD, as assessed by Investigator, or death due to any cause, whichever occurs first (up to 5 months)', 'description': 'PFS is defined as the time from the T-cell infusion to the date of the first documentation of progressive disease (PD) as assessed by investigator assessment or death due to any cause, whichever occurs first.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From T-cell infusion to death due to any reason (up to 7 months)', 'description': 'OS is defined as the time from the date of first T-cell infusion to the date of death (due to any cause).'}, {'measure': 'Replication Competent Lentivirus', 'timeFrame': 'From T-cell infusion to end study (up to 7 months)', 'description': 'The presence of RCL was assessed by qPCR targeting a segment of the vesicular stomatitis virus glycoprotein (VSV G) coding sequence. 1 participant had at least 1 post-infusion sample tested for RCL.\n\nThe count of participants with RCL post-infusion is presented.'}, {'measure': 'Insertional Oncogenesis (IO)', 'timeFrame': 'From 1 year post T-cell infusion', 'description': 'Deoxyribonucleic acid (DNA) from participants peripheral blood mononuclear cell (PBMC) samples are subjected to lentiviral vector integration site analysis by next-generation sequencing, thus evaluating both the clonality status of the transduced cell population and the genomic localization of individual integration sites. The outcome measure is the number of participants with integration sites representing more than 5% of all unique sites.'}, {'measure': 'Peak Persistence', 'timeFrame': 'From T-cell infusion to end study (up to 7 months)', 'description': 'Peak persistence of ADP-A2M4CD8 cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).'}, {'measure': 'Time to Peak Persistence', 'timeFrame': 'From T-cell infusion to end study (up to 7 months)', 'description': 'Time from ADP-A2M4CD8 T-cell infusion to peak persistence of cells.'}, {'measure': 'Concordance of the MAGE A-4 Clinical Trial Assay and in Vitro Diagnostic (IVD) Kit.', 'timeFrame': 'Screening visit', 'description': 'Concordance of the MAGE A-4 clinical trial assay and in vitro diagnostic (IVD) kit.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cell Therapy', 'T Cell Therapy', 'SPEAR T Cell', 'MAGE-A4', 'Immuno-oncology', 'Metastatic', 'Esophagogastric Junction', 'Esophageal Cancer'], 'conditions': ['Esophageal Cancer', 'Esophagogastric Junction Cancer']}, 'descriptionModule': {'briefSummary': 'This study will investigate the efficacy of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose esophageal or esophagogastric junction (EGJ) cancer expresses the MAGE-A4 protein.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age ≥18 and \\<75 years\n* Diagnosis of Esophageal cancer or Esophagogastric junction cancer.\n* Previously received treatment for advanced or metastatic disease.\n* Measurable disease according to RECIST v1.1.\n* HLA-A\\*02 positive\n* Tumor shows MAGE-A4 expression confirmed by central laboratory.\n* ECOG Performance Status of 0 or1.\n* Left ventricular ejection fraction (LVEF) ≥50%.\n\nNote: other protocol defined Inclusion criteria may apply\n\nKey exclusion criteria\n\n1. Positive for any HLA-A\\*02 allele other than: one of the inclusion alleles\n2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study\n3. Active autoimmune or immune mediated disease\n4. Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases\n5. Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease\n6. Uncontrolled intercurrent illness\n7. Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus\n8. Pregnant or breastfeeding\n\nNote: other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04752358', 'briefTitle': 'ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adaptimmune'}, 'officialTitle': 'A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers', 'orgStudyIdInfo': {'id': 'ADP-0055-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autologous genetically modified ADP-A2M4CD8 cells', 'interventionNames': ['Genetic: Autologous genetically modified ADP-A2M4CD8 cells']}], 'interventions': [{'name': 'Autologous genetically modified ADP-A2M4CD8 cells', 'type': 'GENETIC', 'description': 'Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1', 'armGroupLabels': ['Autologous genetically modified ADP-A2M4CD8 cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine- Siteman Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OU Health Stephenson Cancer Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Cancer Institute Franz Clinic', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University Of Texas, MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University Of Wisconsin Clinical Science Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre Glen Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '08035', 'city': "la Vall d'Hebron", 'state': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.43038, 'lon': 2.1483}}, {'zip': '28041', 'city': 'Córdoba', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre'}, {'zip': '46010', 'city': 'Ibáñez', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Valencia'}, {'zip': '228040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Madrid Sanchinarro (CIOCC)', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Navarro', 'country': 'Spain', 'facility': 'Clinica Universidad de Navarra', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adaptimmune', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ICON plc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}