Clinical Study Evaluating the Safety and Efficacy of BAFFR CAR-T Therapy for Relapsed/Refractory B-cell Malignancies

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-78
SponsorDonghua Zhang

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Infusion of BAFFR CAR-T therapy for relapsed/refractory B-cell malignancies

    Drug

    Infusion of BAFFR CAR-T therapy for relapsed/refractory B-cell malignancies

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Experimental:Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

overall survival

Time frame
1,3,6,12,18,24 months after treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Donghua Zhang

Lead sponsor

Tongji Hospital

Sponsor institution