Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT06346912
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': 'Up to 28 years after Treatment', '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 Treatment', 'description': 'Incidence of treatment-emergent adverse events \\[Safety and Tolerability\\]'}], 'secondaryOutcomes': [{'measure': 'Overall response rate ,ORR', 'timeFrame': 'Up to 12 weeks after CAR-T infusion', 'description': 'The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).'}, {'measure': 'Duration of remission ,DOR', 'timeFrame': 'Up to 1 years after CAR-T infusion', 'description': 'The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion'}, {'measure': 'Event-free survival, EFS', 'timeFrame': 'Up to 1 years after CAR-T infusion', 'description': 'The time from first achieving CR/CRi to relapse or death'}, {'measure': 'Overall survival, OS', 'timeFrame': 'Up to 1 years after CAR-T infusion', 'description': 'The time from CAR-T infusion to death due to any cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CD19-BAFF CAR-T'], 'conditions': ['Acute Lymphoblastic Leukemia,B-Cell', 'Non-hodgkin Lymphoma,B Cell']}, 'descriptionModule': {'briefSummary': 'Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.', 'detailedDescription': 'In this study, 20 patients with relapsed refractory B-cell ALL and B-cell NHL were proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19-BAFF CAR-T cell therapy for relapsed refractory B-cell ALL and B-cell NHL; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for relapsed refractory B-cell ALL and B-cell NHL were accumulated, including rare and delayed complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Gender unlimited，18\\< Age;\n* 2\\. Patients diagnosed with B-cell acute lymphoblastic leukemia through histological or immunophenotyping tests; The clear diagnosis of B-cell non Hodgkin's lymphoma by cellular or histopathological examination mainly includes diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma\n* 3\\. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):\n\n 1. CR not achieved after standardized chemotherapy;\n 2. CR achieved following the first induction, but CR duration is less than 12 months;\n 3. Ineffectively after first or multiple remedial treatments;\n 4. 2 or more relapses;\n* 4\\. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \\>5% (by morphology), and/or \\>1% (by flow cytometry);\n* 5\\. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;\n* 6\\. Relapsed or refractory B-NHL (meeting one of the following conditions):\n\n 1. No response or relapse after second-line or above chemotherapy regimens;\n 2. Primary drug resistance;\n 3. Relapse after auto-HSCT;\n* 7\\. At least one assessable tumor lesion per Lugano 2014 criteria;\n* 8\\. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;\n* 9\\. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;\n* 10\\. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;\n* 11\\. Estimated survival time ≥ 3 months;\n* 12\\. ECOG performance status 0 to 2;\n* 13\\. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* 1\\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n* 2\\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n* 3\\. Pregnant/lactating women, or male or female patients with fertility who are unwilling to take effective contraceptive measures during the study period or at least 6 months after the last cell infusion\n* 4\\. Patients with HIV infection;\n* 5\\. Active infection of hepatitis B virus or hepatitis C virus;\n* 6\\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;\n* 7\\. Other uncontrolled diseases that were not suitable for this trial;\n* 8\\. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 6 months;\n* 9\\. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study."}, 'identificationModule': {'nctId': 'NCT06346912', 'briefTitle': 'CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'A Study of CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL', 'orgStudyIdInfo': {'id': 'TXB2023022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Administration of CD19-BAFF Targeted CAR T-cells', 'description': 'Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.', 'interventionNames': ['Biological: CD19-BAFF Targeted CAR T-cells']}], 'interventions': [{'name': 'CD19-BAFF Targeted CAR T-cells', 'type': 'BIOLOGICAL', 'otherNames': ['CD19-BAFF Targeted CAR T-cells injection'], 'description': 'Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion', 'armGroupLabels': ['Administration of CD19-BAFF Targeted CAR T-cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Huang, MD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '86-13605714822'}, {'name': 'Yongxian Hu, MD', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '+8615957162012'}], 'facility': 'The first affiliated hospital of medical college of zhejiang university', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'He Huang, MD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '86-13605714822'}, {'name': 'Yongxian Hu, MD', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '86-15957162012'}], 'overallOfficials': [{'name': 'He Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yake Biotechnology Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'Zhejiang University'}}}}