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
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 and are expected to complete the follow-up examinations and treatment procedures
- Age 18 to 85 years (inclusive), any gender
- 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
- Tumor pathology confirms positive BAFFR target expression at screening
- Patients have recovered from toxicities of previous treatments with CTCAE toxicity grade below 2 (unless abnormalities are tumor-related or stable and not significantly affecting safety or efficacy)
- ECOG performance status 0 to 2 and life expectancy greater than 3 months
- Adequate organ function including ALT and AST less than or equal to 3 times upper limit of normal, total bilirubin less than or equal to 1.5 times upper limit of normal
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance at least 60 mL/min
- Hemoglobin at least 60 g/L or maintained at this level after transfusion
- Room air oxygen saturation at least 92%
- Left ventricular ejection fraction at least 45%
- Accessible venous access for apheresis with no contraindications to leukapheresis
You will not qualify if you...
- History of other malignancies within 3 years prior to screening, except certain treated cancers such as carcinoma in situ of the 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 virus antibody with detectable HCV-RNA
- Positive for human immunodeficiency virus antibody
- History of severe allergies defined as grade 2 or higher allergic reactions or known hypersensitivity to study components
- History of severe cardiac diseases including severe arrhythmia, unstable angina, recent myocardial infarction, heart failure class III or IV, unexplained syncope, severe non-ischemic cardiomyopathy, or refractory hypertension
- Unstable systemic diseases such as severe liver, kidney, or metabolic diseases requiring treatment
- Previous or planned organ transplantation except hematopoietic stem cell transplantation
- Active autoimmune or inflammatory neurological diseases or significant active cerebrovascular disease
- Presence of tumor emergencies requiring urgent treatment
- Uncontrolled infections requiring antibiotic treatment
- Recent use of hematopoietic growth factors affecting blood counts within specified timeframes prior to planned CAR-T manufacturing apheresis
- Use of corticosteroids or immunosuppressive drugs within 2 weeks prior to planned CAR-T manufacturing apheresis affecting cell manufacturing
- Major surgery within 4 weeks prior to lymphodepletion or planned major surgery during the study
- 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, or planning pregnancy within 2 years after cell infusion
- Subjects with contraindications to study procedures or medical conditions posing unacceptable risks as judged by the investigator
AI-Screening
AI-Powered Screening
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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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