Phase III Study of Fully Human BAFF-R CAR-T Cell Therapy for Adults with Relapsed or Refractory BAFF-R-Positive B-Cell Lymphoma

What this Trial Is About

Researchers are studying the safety and best dose of BAFF-R Chimeric Antigen Receptor T-Cell Injection BAFF-R CAR-T in adults with relapsed or refractory BAFF-R-positive B-cell lymphoma. They are also exploring how well this treatment works and how it behaves in the body, including its effects on different immune cells. This is a phase III dose-escalation clinical trial designed to find the maximum tolerated dose and evaluate preliminary efficacy. Participants receive one of three doses of BAFF-R CAR-T cells, given as a single intravenous infusion after a chemotherapy preconditioning regimen with fludarabine and cyclophosphamide. The study follows a 33 dose escalation design with 14-day intervals between infusions in each dose group. After dose escalation, an expansion phase will enroll up to 20 participants at the selected optimal dose to further assess safety and effectiveness. Participants undergo a screening period, followed by blood collection for CAR-T cell preparation, which takes about 15 to 25 days. Before infusion, they receive chemotherapy to prepare the body. After the CAR-T infusion, they are monitored through physical exams, vital signs, lab tests, imaging, and treatment efficacy evaluations at set intervals up to 24 months. Researchers track safety outcomes and measure responses such as remission and survival rates during this follow-up.

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