Clinical Trial

Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed/Refractory BAFF-R-Positive B-Cell Lymphoma

Recruiting Phase 1/2
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Summary
The aim of this study is to analyze the safety of BAFF-R Chimeric Antigen Receptor T-Cell Injection (BAFF-R CAR-T) in participants with relapsed/refractory BAFF-R-positive B-cell lymphoma and explore the Maximum Tolerated Dose (MTD). The secondary objective of this study is to explore the efficacy of BAFF-R CAR-T in participants with relapsed/refractory BAFF-R-positive B-cell lymphoma. The study also aims to explore the pharmacokinetic characteristics of BAFF-R CAR-T in vivo and the impact of BAFF-R CAR-T on lymphocyte subsets in vivo.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-21.
Status change: Not Yet Recruiting → Recruiting 2026-05-10
Trial Details
NCT Number NCT07259070
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Collaborators: Hebei Taihe Chunyu Biotechnology Co., Ltd
Conditions DLBCL, CLL, FL, MCL, WM, MZL
Enrollment 20 participants
Start Date 2025-11-29
Primary Completion 2029-11-28 (estimated)
Study Completion 2029-11-28 (estimated)
Updated on ClinicalTrials.gov 2026-05-13