Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-11 @ 11:51 AM
Study NCT ID:
NCT03888859
Status:
COMPLETED
Last Update Posted:
2021-03-29
First Post:
2019-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ET1402L1-ARTEMIS™2 T Cells in Alpha Fetoprotein (AFP) Expressing Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2019-02-01', 'studyFirstSubmitQcDate': '2019-03-22', 'lastUpdatePostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with dose-limiting toxicity', 'timeFrame': '28 days up to 2 years', 'description': 'A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ET1402L1-ARTEMIS™2 T-cells, which is irreversible, or life threatening or CTCAE Grade 3-5. Assessed at all visits.'}, {'measure': 'Frequency of ARTEMIS T cell treatment-related adverse events', 'timeFrame': 'Time Frame: 28 days up to 2 years', 'description': 'Include but not limited to: Fever, chills, nausea, vomiting, jaundice and other gastrointestinal symptoms; Fatigue, hypotension, respiratory distress; Tumor lysis syndrome; Cytokine release syndrome; Neutropenia, thrombocytopenia; Liver and kidney dysfunction. Assessed at all visits.'}], 'secondaryOutcomes': [{'measure': 'Rate of disease response by RECIST in the liver', 'timeFrame': '2 years', 'description': 'Response rates will be estimated as the percent of patients with objective response (OR)，which was defined as any of complete remission (CR), partial response (PR) at 2 years.'}, {'measure': 'Rate of disease response by RECIST at non-liver sites', 'timeFrame': '2 years', 'description': 'Response rates will be estimated as the percent of patients with objective response (OR)，which was defined as any of complete remission (CR), partial response (PR) at 2 years.'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'at 4 months, 1 year, 2 years', 'description': 'Progression free survival (PFS) at 4 months, 1 year and 2 years'}, {'measure': 'Median Survival（MS）', 'timeFrame': 'at 4 months, 1 year, 2 years', 'description': 'Median Survival（MS）at 4 months, 1 year and 2 years'}, {'measure': 'Overall survival（OS）', 'timeFrame': 'at 2 years', 'description': 'overall survival（OS）at 2 years'}, {'measure': 'AFP serum levels', 'timeFrame': '2 years', 'description': 'Percent change compared to the baseline'}, {'measure': 'Number of ET1402L1-ARTEMIS™2 T cells in peripheral blood', 'timeFrame': '2 years', 'description': 'Number of ET1402L1-ARTEMIS™2 T cells in peripheral blood will be presented as Time to peak, Time to baseline level'}, {'measure': '% of ET1402L1-ARTEMIS™2 T cells in peripheral blood', 'timeFrame': '2 years', 'description': '%of ET1402L1-ARTEMIS™2 T cells in peripheral blood will be presented as Time to peak, Time to baseline level'}, {'measure': 'AFP expression in tumors', 'timeFrame': '4-8 weeks', 'description': 'Percent of AFP-positive cells in randomly selected fields in tumor biopsies.'}, {'measure': 'Tmax of serum Interleukin (IL)-2, IL-4, IL-6, IL-10, Tumor necrosis factor(TNF)-α and Interferon gamma (INFγ)', 'timeFrame': '24 weeks', 'description': 'Increase or decreases in the amount of serum IL-2, IL-4, IL-6, IL-10, TNF-α and INF-γ produced compared to baseline at time points measured up to 24 weeks since dosing. Data will be presented as time to peak level for Tmax.'}, {'measure': 'AUC of serum IL-2, IL-4, IL-6, IL-10, TNF-α and INFγ', 'timeFrame': '24 weeks', 'description': 'Increase or decreases in the amount of serum IL-2, IL-4, IL-6, IL-10, TNF-α and INFγ produced compared to baseline at time points measured up to 24 weeks since dosing. Data will be presented as time to peak level for area under curve (AUC).'}, {'measure': 'Time to baseline for serum IL-2, IL-4, IL-6, IL-10, TNF-α and INFγ', 'timeFrame': '24 weeks', 'description': 'Increase or decreases in the amount of IL-2, IL-4, IL-6, IL-10, TNF-α and INFγ produced compared to baseline at time points measured up to 24 weeks since dosing.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma', 'Liver Cancer', 'Liver Neoplasms', 'Metastatic Liver Cancer']}, 'descriptionModule': {'briefSummary': 'Clinical study to evaluate safety (primary objectives) and efficacy (secondary objective) of ET1402L1-ARTEMIS™2 T cells in patients with alpha fetoprotein positive (AFP+ ) hepatocellular carcinoma (HCC).', 'detailedDescription': 'The molecular target for ET1402L1-ARTEMIS™2 is human leukocyte antigen (HLA) -A02 complexed with a HLA-A02-restricted peptide of alpha fetoprotein (AFP), which is expressed on 60-80 percent of hepatocellular carcinoma (HCC). ARTEMIS™2 is a second generation ARTEMIS™ receptor engineered with a human antibody domain against the anti-HLA-A02/AFP complex. This clinical study evaluates the safety and pharmacokinetics of ET1402L1-ARTEMIS™2 T-cells in patients with HCC who have no available curative therapeutic options and a poor overall prognosis.\n\nPatients with lesion(s) localized in liver will be enrolled in the intra-hepatic artery (IA) arm or Intratumoral Injections arm, with the ET1402L1-ARTEMIS™2 T-cells administered via intrahepatic artery catheter. Patients with extrahepatic metastasis will be enrolled in the intravenous (IV) arm, with the ET1402L1-ARTEMIS™2 T-cells administered through intravenous infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AFP-expressing HCC and serum AFP \\>100 ng/mL.\n* Abandon or failure in first or second line treatment\n* Molecular HLA class I typing confirms participant carries at least one HLA-A02 allele\n* Child-Pugh score of A or B, Barcelona Clinic Liver Cancer stage of C or D\n* Life expectancy \\> 4 months\n* Karnofsky score ≥70%\n* Adequate organ function as defined below:\n\n 1. Patients must have a serum Total bilirubin ≤2 x Upper Limit of Normal (ULN), Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤5 times the institutional ULN.\n 2. A pretreatment measured creatinine clearance (absolute value) of ≥ 50 ml/minute\n 3. Ejection fraction measured by echocardiogram or Multiple gated acquisition scanning (MUGA) \\>45% (evaluation done with 6 weeks of screening does not need to be repeated)\n 4. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) or Forced Expiratory Volume in the first second (FEV1)\\>45% predicted\n 5. Absolute neutrophil count (ANC) ≥ 1500/mm3 (10\\^9/L)\n 6. Platelet count ≥ 50,000/mm3 (10\\^9/L)\n* Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Patients with decompensated cirrhosis: Child-Pugh Score C\n* Patients with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver.\n* Patients with an organ transplantation history\n* Patients with dependence on corticosteroids\n* Patients with active autoimmune diseases requiring systemic immunosuppressive therapy\n* Patients who are currently receiving or received within past 30 days anti-cancer therapy, local treatments for liver tumors (radiotherapy, embolism, ablation) or liver surgery\n* Patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy)\n* Participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within two years. Patients with a history of successfully-treated tumors with no sign of recurrence in the last two years may be enrolled.\n* Patients with other uncontrolled diseases, such as active infections\n* Acute or chronic active hepatitis B or hepatitis C.\n* Women who are pregnant or breast-feed\n* HIV-infection'}, 'identificationModule': {'nctId': 'NCT03888859', 'briefTitle': 'ET1402L1-ARTEMIS™2 T Cells in Alpha Fetoprotein (AFP) Expressing Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Phase 1, Open-label, Three Routes IV, Intratumoral Injections and Intra-hepatic Artery Dose-escalation Clinical Study to Evaluate the Safety and Efficacy of ET1402L1-ARTEMIS™2™ T- Cells in AFP Expressing Hepatocellular Carcinoma (HCC)', 'orgStudyIdInfo': {'id': 'XJTU1AF2017LSL-C002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous (i.v.) arm', 'description': 'autologous ET1402L1-ARTEMIS™2 T cells administered by intravenous (IV) infusion', 'interventionNames': ['Biological: ET1402L1-ARTEMIS™ T cells -IV']}, {'type': 'EXPERIMENTAL', 'label': 'Intra-hepatic artery (i.a.) arm', 'description': 'autologous ET1402L1-ARTEMIS™2 T cells administered by intra-hepatic artery (IA) infusion', 'interventionNames': ['Biological: ET1402L1-ARTEMIS™ T cells -intra-hepatic artery']}, {'type': 'EXPERIMENTAL', 'label': 'Intratumoral Injections (i.t.) arm', 'description': 'autologous ET1402L1-ARTEMIS™2 T cells administered by intratumoral injections (i.t.) infusion', 'interventionNames': ['Biological: ET1402L1-ARTEMIS™ T cells -Intratumoral Injections']}], 'interventions': [{'name': 'ET1402L1-ARTEMIS™ T cells -IV', 'type': 'BIOLOGICAL', 'description': 'Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct -intravenous (i.v.) arm', 'armGroupLabels': ['Intravenous (i.v.) arm']}, {'name': 'ET1402L1-ARTEMIS™ T cells -intra-hepatic artery', 'type': 'BIOLOGICAL', 'description': 'Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct: intra-hepatic artery (i.a.) arm', 'armGroupLabels': ['Intra-hepatic artery (i.a.) arm']}, {'name': 'ET1402L1-ARTEMIS™ T cells -Intratumoral Injections', 'type': 'BIOLOGICAL', 'description': 'Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct: Intratumoral Injections (i.t.) arm', 'armGroupLabels': ['Intratumoral Injections (i.t.) arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'country': 'China', 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Chang Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Eureka Therapeutics Inc.', 'class': 'INDUSTRY'}, {'name': 'Aeon Therapeutics (Shanghai) Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}