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

NCT ID: NCT07345728

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2029-06-01

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.

Conditions

Relapsed/Refractory B-cell Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental:Experimental group

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

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 × ULN;

4. Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min;

5. Hemoglobin ≥ 60 g/L or maintained at this level after transfusion;

6. Room air oxygen saturation ≥ 92%;

7. Left ventricular ejection fraction (LVEF) ≥ 45%; Accessible venous access for apheresis and no contraindications to leukapheresis.

Exclusion Criteria

Receiving corticosteroids or immunosuppressive drugs within 2 weeks prior to planned CAR-T manufacturing apheresis, and judged by the investigator to affect cell manufacturing:

1. 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);

2. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Donghua Zhang

OTHER

Sponsor Role: lead

Responsible Party

Donghua Zhang

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Andie Fu

Role: primary

andie_fu@163.com

15926614832

Other Identifiers

DHZ1962-A

Identifier Type: -

Identifier Source: org_study_id