Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-28 @ 1:15 AM
Study NCT ID:
NCT04740203
Status:
UNKNOWN
Last Update Posted:
2021-02-05
First Post:
2021-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2021-01-31', 'studyFirstSubmitQcDate': '2021-02-04', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': 'Baseline up to 28 days after CAR-T cells infusion', 'description': 'Adverse events assessed according to NCI-CTCAE v5.0 criteria'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 2 years after CAR-T cells infusion', 'description': 'Incidence of treatment-emergent adverse events \\[Safety and Tolerability\\]'}], 'secondaryOutcomes': [{'measure': 'Complete Remission Rate', 'timeFrame': 'up to 28 days after CAR-T cells infusion', 'description': 'Complete Remission Rate after CAR-T cell therapy'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 2 years after CD19 CAR-T cells infusion', 'description': 'From the first infusion of CD19 CAR-T cells to death or the last visit'}, {'measure': 'Leukemia-free survival (LFS)', 'timeFrame': 'Up to 2 years after CD19 CAR-T cells infusion', 'description': 'From the complete remission to the occurrence of any event, including death, relapse (any one occurs first), and the last visit'}, {'measure': 'Quality of life', 'timeFrame': 'At Baseline, Month 1, 3, 6, 9 and 12', 'description': 'Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale \\[For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome\\] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CD19 CAR-T', 'CD22 CAR-T', 'Ph Chromosome Negative', 'B-ALL', 'Newly diagnosed'], 'conditions': ['B-Cell Acute Lymphoblastic Leukemia, Adult']}, 'descriptionModule': {'briefSummary': 'Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia', 'detailedDescription': 'This is a prospective, single arm study. To evaluate the safety and efficacy of sequential CD19 and CD22 CAR-T cells in the treatment of adult newly diagnosed Ph chromosome negative B-cell acute lymphoblastic leukemia. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ageā„15 years old\n* Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification\n* The immunophenotype of leukemia cells were CD19 and CD22 positive\n* Ph- or Ph- like negative\n* Anticipated survival time more than 12 weeks;\n* Those who voluntarily participated in this trial and provided informed consent.\n\nExclusion Criteria:\n\n* History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n* Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n* Pregnant (or lactating) women;\n* Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);\n* Active infection of hepatitis B virus or hepatitis C virus;\n* Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;\n* Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;\n* Creatinine\\>2.5mg/dl, or ALT / AST \\> 3 times of normal amounts, or bilirubin\\>2.0 mg/dl;\n* Other uncontrolled diseases that were not suitable for this trial;\n* Patients with HIV infection;\n* Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.'}, 'identificationModule': {'nctId': 'NCT04740203', 'briefTitle': 'Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': 'CD19-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR-T therapy', 'description': 'Administration of CD19 and CD22 CAR T-cells', 'interventionNames': ['Drug: CAR-T cells targeting CD19 and CD22']}], 'interventions': [{'name': 'CAR-T cells targeting CD19 and CD22', 'type': 'DRUG', 'description': 'Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion', 'armGroupLabels': ['CAR-T therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Huang, PhD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '86-13605714822'}], 'facility': 'The First Affiliated Hospital, College of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'He Huang, PhD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '86-13605714822'}, {'name': 'Mingming Zhang, PhD', 'role': 'CONTACT', 'email': 'mingmingzhang@zju.edu.cn', 'phone': '86-13656674208'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yake Biotechnology Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'Zhejiang University'}}}}