Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 4:13 AM
Study NCT ID:
NCT07369492
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-01-18', 'studyFirstSubmitQcDate': '2026-01-18', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose-limiting toxicity (DLT)', 'timeFrame': '1 month after injection', 'description': 'Dose-limiting toxicity for each subject'}, {'measure': 'AE/SAE', 'timeFrame': '1 month, 3 months, 6 months, 12 months after injection', 'description': 'Incidence and severity of adverse events (AE), and serious adverse event (SAE)'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '1 month, 3 months, 6 months, 9 months, 12 months after injection', 'description': 'Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '1 month, 3 months, 6 months, 9 months, 12 months after injection', 'description': 'Defined as the time from the date of first infusion to death due to any cause'}, {'measure': 'Duration of response (DOR)', 'timeFrame': '1 month, 3 months, 6 months, 9 months, 12 months after injection', 'description': 'The time from the date of first response (PR or better) to the date of disease progression after infusion'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '1 month, 3 months, 6 months, 9 months, 12 months after injection', 'description': 'The time from first infusion to the date of progression or death.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of BAFF-R CAR-T Cells in Adult Subjects with CD19-Negative relapsed or refractory B-Cell Lymphoma.', 'detailedDescription': 'This is a prospective open-label, single-arm clinical study to evaluate the safety, tolerability of BAFF-R CAR-T cells in adult subjects with CD19-negative relapsed or refractory B-Cell Lymphoma. The study plans to explore across three dose levels (1.00 × 10\\^6, 3.00 × 10\\^6, 9.00 × 10\\^6 CAR+ T cells/kg), and 6.00×10\\^8 CAR+T cells as maximum dose, aiming to evaluate the safety, tolerability of BAFF-R CAR-T cells in CD19-negative relapsed or refractory B-Cell Lymphoma, explore Maximum Tolerated Dose (MTD) and determine the recommended dose for Phase II. Besides, efficacy, pharmacokinetics and persistence profile of CAR-T cells are also study objectives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Subjects voluntarily participate in clinical research and sign informed consent.\n* 2\\. Subjects with CD19-negative relapsed or refractory B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months; b) achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; c) not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation).\n* 3\\. Expected survival ≥ 3 months.\n* 4\\. BAFF-R expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry.\n* 5\\. ECOG score ≤ 2.\n* 6\\. Subjects with adequate organ functions prior to enrollment, meet the following laboratory values:\n* Renal function: serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m²\n* Hepatic function: Serum alanine aminotransferase (ALT) ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg/dL, except in subjects with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN, subjects with Gilbert-Meulengracht syndrome are included.\n* Pulmonary reserve: ≤ Grade 1 dyspnea and oxygen saturation \\>95% on room air.\n* 7\\. Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA).\n* 8\\. Adequate bone-marrow reserve without blood transfusion as defined by:\n* Absolute neutrophil count (ANC) ≥ 1 x 10\\^9/L.\n* Absolute lymphocyte count (ALC) ≥ 0.1 x 10\\^9/L.\n* Platelets ≥ 50 x 10\\^9/L.\n* Hemoglobin \\>80g/L.\n* 9\\. In the investigator's judgment, subjects' general condition and all biochemical values are either normal or sufficiently compensated to receive lymphodepletion and CAR-T cell therapy.\n\nExclusion Criteria:\n\n* 1\\. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.\n* 2\\. Infectious disease(HIV, Active Tuberculosis ect.).\n* 3\\. Active infection: hepatitis B, hepatitis C.\n* 4\\. Abnormal vital signs or refuse to receive examination.\n* 5\\. Subjects with psychiatric or psychological disorders are unable to complete treatment or efficacy assessment.\n* 6\\. History of severe hypersensitivity or known hypersensitivity to IL-2.\n* 7\\. Systemic or local severe infection requiring antimicrobial therapy.\n* 8\\. Significant dysfunction of vital organs (heart, lung, brain, kidney, etc.), or in the investigator's judgment, subjects are unable to be enrolled with any other condition."}, 'identificationModule': {'nctId': 'NCT07369492', 'briefTitle': 'Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Topcel-KH Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Prospective, Open-label and Single-arm Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma', 'orgStudyIdInfo': {'id': 'TH-RD09-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAFF-R CAR-T Cells treatment arm', 'description': 'Subjects will be administrated with BAFF-R CAR-T Cells after lymphocyte depletion by fludarabine and cyclophosphamide.', 'interventionNames': ['Biological: BAFF-R CAR-T cells']}], 'interventions': [{'name': 'BAFF-R CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'BAFF-R CAR-T cells, single intravenous infusion', 'armGroupLabels': ['BAFF-R CAR-T Cells treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao Ma', 'role': 'CONTACT', 'email': 'colleenld2020@hotmail.com', 'phone': '0512-83837999'}], 'facility': 'Suzhou Hongci Hematology Hospital', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Xiao Ma', 'role': 'CONTACT', 'email': 'colleenld2020@hotmail.com', 'phone': '0512-83837999'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Topcel-KH Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}