Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-18 @ 6:24 AM
Study NCT ID:
NCT04605666
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2020-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19-CAR-T2 Cells for CD19 Positive B Cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'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'}, {'id': 'D008223', 'term': 'Lymphoma'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-18', 'studyFirstSubmitDate': '2020-10-25', 'studyFirstSubmitQcDate': '2020-10-25', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': '3 months', 'description': "Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis."}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': '6 months'}, {'measure': 'ORR', 'timeFrame': '12 months'}, {'measure': 'Adverse Events', 'timeFrame': '12 months'}, {'measure': 'OS', 'timeFrame': '1 year', 'description': 'overall survival'}, {'measure': 'DFS', 'timeFrame': '1 year', 'description': 'disease-free survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR-T'], 'conditions': ['B Cell Leukemia', 'B Cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '40426201', 'type': 'DERIVED', 'citation': 'He B, Lin R, Xu N, Qin L, Wang Z, Wang Q, Li X, Wei X, Wei Y, Tang Z, Fan Z, Huang F, Liu X, Sun J, Xuan L, Li P, Zhou H, Liu Q. Efficacy and safety of third-generation CD19-CAR T cells incorporating CD28 and TLR2 intracellular domains for B-cell malignancies with central nervous system involvement: results of a pivotal trial. J Transl Med. 2025 May 27;23(1):594. doi: 10.1186/s12967-025-06608-x.'}]}, 'descriptionModule': {'briefSummary': 'Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of third-generation anti-CD19 CAR T-cells (CD19-CAR-T2 Cells) in patients with CD19+ relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell Non Hodgkin Lymphoma (B-NHL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with relapsed and/or refractory CD19+ B-cell leukemia or lymphoma\n* Eastern Cooperative Oncology Group (ECOG) performance status \\<2\n* ALT/ AST \\<3 x normal\n* Bilirubin \\< 2.0 mg/dl\n* Creatinine \\< 2.5 mg/dl and less than 2.5x normal for age\n* LVEF\\< 45%\n* Accept white blood cell collection\n* Provide informed consent\n\nExclusion Criteria:\n\n* Previous treatment with investigational gene or cell therapy medicine products\n* Active hepatitis B , hepatitis C or HIV infection\n* Uncontrolled active infection\n* Presence of grade 2-4 acute or extensive chronic GVHD\n* Any uncontrolled active medical disorder that would preclude participation as outlined.\n* Received non-diagnostic purposes major surgery within the past 4 weeks\n* Participated in any other clinical study within the past 4 weeks\n* Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.\n* Pregnancy or breast-feeding women\n* Use of prohibited drugs:\n* Steroids: Therapeutic doses of steroids must be stopped \\> 72 hours prior to CD19-CAR-T2 Cells infusion\n* Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \\> 4 weeks prior to CD19-CAR-T2 Cells infusion\n* GVHD therapies: Any drug used for GVHD must be stopped \\> 4 weeks prior to CD19-CAR-T2 Cells infusion\n* Any situation that may increase the risk of the test or interfere with the test results'}, 'identificationModule': {'nctId': 'NCT04605666', 'briefTitle': 'CD19-CAR-T2 Cells for CD19 Positive B Cell Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'CD19-Chimeric Antigen Receptor-T2 Cells for CD19 Positive Relapsed/Refractory B Cell Leukemia/Lymphoma', 'orgStudyIdInfo': {'id': 'NFEC-2020-098'}, 'secondaryIdInfos': [{'id': 'NFEC-2020-098', 'type': 'OTHER', 'domain': 'Nanfang Hospital-Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR-T group', 'interventionNames': ['Biological: CD19-CAR-T2 Cells']}], 'interventions': [{'name': 'CD19-CAR-T2 Cells', 'type': 'BIOLOGICAL', 'description': 'CD19-CAR-T2 T cells will be infused over 10-15 minutes on Day 0.', 'armGroupLabels': ['CAR-T group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Qi-fa Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}