Actively Recruiting
Clinical Study Evaluating the Safety and Efficacy of BAFFR CAR-T Therapy for Relapsed/Refractory B-cell Malignancies
Led by Donghua Zhang · Updated on 2026-01-16
28
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating BAFFR CAR-T therapy for people with relapsed or refractory B-cell malignancies, cancers that have returned or do not respond to treatment. This prospective, single-arm, multi-center clinical study aims to assess the safety and effectiveness of this therapy. The trial plans to enroll 30 participants aged 18 to 85 years who have previously undergone treatments including anti-CD20 agents and anthracycline-containing regimens, with confirmed BAFFR target expression on their tumors. Participants will receive an infusion of the BAFFR CAR-T therapy designed specifically for their condition. The study involves monitoring safety and treatment outcomes after the infusion, with no placebo or comparison groups. The treatment requires accessible venous access for apheresis, and participants must have recovered from previous treatment toxicities. The study will track participants over time to evaluate overall survival at multiple points from 1 month up to 24 months after treatment. During the study, participants will undergo follow-up examinations and treatment procedures as scheduled. Researchers will measure overall survival rates to understand the therapy's impact. Patients are required to have adequate organ function and performance status to safely participate. Safety monitoring includes assessing organ function, infections, and allergic reactions. The total duration of involvement includes treatment and long-term follow-up until at least two years after the infusion to observe outcomes and potential side effects.
CONDITIONS
Brief Title
Clinical Study Evaluating the Safety and Efficacy of BAFFR CAR-T Therapy for Relapsed/Refractory B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients or their guardians understand and voluntarily sign the informed consent form
- Age 18 to 85 years (inclusive), any gender
- Diagnosed with relapsed/refractory B-cell lymphoma
- Have received prior treatment including anti-CD20 targeted agents (unless CD20 negative) and anthracycline-containing regimens
- Tumor confirmed positive for BAFFR target expression by pathological immunohistochemistry at screening
- Recovered from previous treatment toxicities with CTCAE toxicity grade less than 2 (unless tumor-related or stable)
- ECOG performance status 0 to 2 and life expectancy more than 3 months
- Adequate organ function including ALT ≤ 3 × ULN, AST ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min
- Hemoglobin ≥ 60 g/L or maintained after transfusion
- Room air oxygen saturation ≥ 92%
- Left ventricular ejection fraction ≥ 45%
- Accessible venous access for apheresis with no contraindications to leukapheresis
You will not qualify if you...
- History of other malignancies within 3 years except treated carcinoma in situ of cervix, papillary thyroid cancer, basal or squamous cell skin cancer, localized prostate cancer after radical therapy, and ductal carcinoma in situ after radical therapy
- Positive for hepatitis B surface antigen or hepatitis B core antibody with detectable HBV DNA
- Positive for hepatitis C antibody with positive HCV-RNA
- Positive for human immunodeficiency virus antibody
- History of severe allergies or known hypersensitivity to study components including lymphodepletion regimen
- History of severe cardiac disease or recent myocardial infarction or cardiac surgery within 6 months
- Unstable systemic disease including severe liver, kidney, or metabolic diseases
- Previous or planned organ transplantation except hematopoietic stem cell transplantation
- Active autoimmune or inflammatory neurological diseases or significant cerebrovascular disease
- Presence of tumor emergencies requiring urgent treatment
- Uncontrolled infections requiring antibiotics
- Use of hematopoietic growth factors or immunosuppressive drugs within specified timeframes before CAR-T manufacturing apheresis
- Major surgery within 4 weeks prior to lymphodepletion or planned during study
- Vaccination with live-attenuated viral vaccines within 4 weeks prior to screening
- History of severe mental illness, alcoholism, or substance abuse
- Pregnant or lactating women or planning pregnancy within 2 years after infusion
- Contraindications to study procedures or other medical conditions posing unacceptable risks as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until disease progression or discontinuation
Participants receive infusion of BAFFR CAR-T therapy for relapsed/refractory B-cell malignancies.
Duration - Up to 24 months after treatment
Participants are monitored for overall survival and safety after treatment.
Visits at 1, 3, 6, 12, 18, and 24 months after treatment
Trial Site Locations
Total: 1 location
1
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China, 448000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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