Clinical Study Evaluating the Safety and Efficacy of BAFFR CAR-T Therapy for Relapsed/Refractory B-cell Malignancies
Trial Parameters
Brief Summary
This is a prospective, single-arm, multi-center, randomized controlled clinical study designed to evaluate the safety and efficacy of BAFFR CAR-T therapy for relapsed/refractory B-cell malignancies. A total of 30 subjects are planned to be enrolled.
Eligibility Criteria
Inclusion Criteria: Patients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examinations and treatment procedures of the study; Age 18-85 years (inclusive), gender not restricted; Patients with relapsed/refractory B-cell lymphoma who have received prior treatment including anti-CD20 targeted agents (unless documented CD20 negative) and anthracycline-containing regimens; Pathological immunohistochemistry of tumor confirms positive BAFFR target expression at screening; Patients have recovered from the toxicities of previous treatments, i.e., CTCAE toxicity grade \< 2 (unless abnormalities are tumor-related or judged by the investigator to be stable and not significantly affecting safety or efficacy); ECOG performance status 0-2 and life expectancy \> 3 months; Adequate organ function: 1. Alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN); 2. Aspartate transaminase (AST) ≤ 3 × ULN; 3. Total bilirubin ≤ 1.5