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Recruiting Phase 1 NCT07369492

Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma

Trial Parameters

Condition B-cell Lymphoma
Sponsor Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-01-01
Completion 2027-01
Interventions
BAFF-R CAR-T cells

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 1\. Subjects voluntarily participate in clinical research and sign informed consent. * 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). * 3\. Expected survival ≥ 3 months. * 4\. BAFF-R expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry. * 5\. ECOG score ≤ 2. * 6\. Subjects with adequate organ functions prior to enrollment, meet the following laboratory values: * Renal function: serum creatinine ≤ 1.5 × ULN or estimated glomerular filtra

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