About this trial
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
Qualifiers
Alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN);
Aspartate transaminase (AST) ≤ 3 × ULN;
Total bilirubin ≤ 1.5 × ULN;
Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min;
Disqualifiers
Corticosteroids: Subjects receiving systemic steroid therapy within 2 weeks prior to planned CAR-T manufacturing apheresis and judged by the investigator to require long-term systemic steroid therapy during treatment (except inhaled or topical use); and subjects receiving systemic steroid therapy within 72 hours before cell infusion (except inhaled or topical use);
Immunosuppressants: Subjects receiving immunosuppressive agents within 2 weeks prior to planned CAR-T manufacturing apheresis; Major surgery (except diagnostic procedures and biopsies) within 4 weeks prior to lymphodepletion or planned major surgery during the study, or incompletely healed surgical wounds before enrollment; Vaccination with (live-attenuated) viral vaccines within 4 weeks prior to screening; History of severe mental illness; History of alcoholism or substance abuse; Pregnant or lactating women, and female subjects planning pregnancy within 2 years after cell infusion or male subjects whose partners plan pregnancy within 2 years after their cell infusion; Subjects with contraindications to any study procedures or other medical conditions that may pose unacceptable risks according to the investigator's judgment and/or clinical standards.
Trial design
Treatments tested in this trial
- Infusion of BAFFR CAR-T therapy for relapsed/refractory B-cell malignancies
Treatment groups
Sponsors and collaborators
Donghua Zhang
Lead sponsor
Tongji Hospital
Sponsor institution