Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT04594135
Status:
UNKNOWN
Last Update Posted:
2021-03-02
First Post:
2020-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054218', 'term': 'Precursor T-Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D015458', 'term': 'Leukemia, T-Cell'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-27', 'studyFirstSubmitDate': '2020-10-14', 'studyFirstSubmitQcDate': '2020-10-14', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events after anti-CD5 CAR T cells cell infusion', 'timeFrame': '2 years particularly the first 28 days after infusion', 'description': 'Determine the toxicity profile of anti-CD5 CAR T cell therapy'}], 'secondaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events', 'timeFrame': 'up to 6 months', 'description': 'Incidence of treatment-emergent adverse events'}, {'measure': 'Disease Free Survival (DFS)', 'timeFrame': 'up to 2 years', 'description': 'Disease Free Survival (DFS)'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'up to 2 years', 'description': 'Progression-Free Survival (PFS)'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'up to 2 years', 'description': 'Overall Survival (OS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anti-CD5 CAR', 'T cell leukemia/lymphoma', 'T-ALL'], 'conditions': ['T-cell Acute Lymphoblastic Leukemia', 'T-cell Non-Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD5 CART cells in patients with relapsed and/or refractory T cell lymphoma or leukemia.', 'detailedDescription': 'Anti- CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD5 antigen. CD5+ T cell lymphomas or leukemia are a subset of leukemias and lymphomas that are positive for the surface protein CD5. The purpose of this study is to evaluate the efficacy and safety of anti-CD5 CAR T cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written informed consent; Patients volunteer to participate in the research\n2. Diagnosis is mainly based on the World Health Organization (WHO) 2008\n3. Patients have exhausted standard therapeutic options\n4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks\n5. Female must be not pregnant during the study\n\nExclusion Criteria:\n\n1. Patients declining to consent for treatment\n2. Prior solid organ transplantation\n3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant\n4. Any drug used for GVHD must be stopped \\>1 week'}, 'identificationModule': {'nctId': 'NCT04594135', 'acronym': 'CD5CAR-T', 'briefTitle': 'Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'iCell Gene Therapeutics'}, 'officialTitle': 'Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies', 'orgStudyIdInfo': {'id': 'ICG190-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anti-CD5 CAR T cells', 'description': 'Experimental: anti-CD5 CAR T cells Dose escalation phase: anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells with an escalation approach, 1e6 to 5e6 CAR-T cells/kg', 'interventionNames': ['Drug: anti-CD5 CAR T cells']}], 'interventions': [{'name': 'anti-CD5 CAR T cells', 'type': 'DRUG', 'description': 'anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells', 'armGroupLabels': ['anti-CD5 CAR T cells']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongyu Zhang, MD/PhD', 'role': 'CONTACT', 'email': 'Hongyu.Zhang@pkuszh.com'}], 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Kevin G Pinz, MS', 'role': 'CONTACT', 'email': 'kevin.pinz@icellgene.com', 'phone': '6315386218'}], 'overallOfficials': [{'name': 'Hongyu Zhang, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Shenzhen Hospital, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iCell Gene Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'iCAR Bio Therapeutics Ltd.', 'class': 'INDUSTRY'}, {'name': 'Peking University Shenzhen Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}