Actively Recruiting
Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed/Refractory BAFF-R-Positive B-Cell Lymphoma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-05-13
20
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
H
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to analyze the safety of BAFF-R Chimeric Antigen Receptor T-Cell Injection (BAFF-R CAR-T) in participants with relapsed/refractory BAFF-R-positive B-cell lymphoma and explore the Maximum Tolerated Dose (MTD). The secondary objective of this study is to explore the efficacy of BAFF-R CAR-T in participants with relapsed/refractory BAFF-R-positive B-cell lymphoma. The study also aims to explore the pharmacokinetic characteristics of BAFF-R CAR-T in vivo and the impact of BAFF-R CAR-T on lymphocyte subsets in vivo.
CONDITIONS
Official Title
Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed/Refractory BAFF-R-Positive B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory BAFF-R-positive B-cell lymphoma confirmed by guidelines
- Measurable lesion or bone marrow involvement as defined by lymphoma criteria
- Specific lymphoma types including MCL, CLL, DLBCL, FL, MZL, and WM with required prior treatments
- Age between 18 and 75 years
- Expected survival of at least 12 weeks
- Liver and kidney function within defined limits
- ECOG performance status of 0 or 1
- Left ventricular ejection fraction of 50% or higher and oxygen saturation above 91%
- Agreement to use effective contraception during the study and negative pregnancy test for women of childbearing potential
- Voluntary participation with signed informed consent form
You will not qualify if you...
- Allergy to any component of the cellular product
- Acute or chronic graft-versus-host disease requiring recent systemic treatment
- Receipt of live vaccine within 4 weeks prior to enrollment
- Central nervous system diseases unrelated to lymphoma involvement
- Severe active infections or current intravenous antibiotic therapy (except certain infections)
- Positive for hepatitis B or C infection or other immunodeficiency diseases including HIV
- Heart failure classified as NYHA Grade III or IV
- History of other primary malignancies except certain cured cases
- History of solid organ transplantation
- History of autoimmune diseases or requiring immunosuppressive therapy
- Participation in other interventional clinical trials within 3 months
- Pregnant or breastfeeding women
- Psychiatric disorders, consciousness disturbances, or CNS diseases
- Unresolved toxic effects of prior treatments above Grade 2
- Recent use of therapeutic-dose corticosteroids or systemic antineoplastic therapy not discontinued as required
- Active pulmonary infections
- Contraindications to peripheral blood apheresis
- Other reasons deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
S
Shuhua Yi,Dr
CONTACT
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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