Actively Recruiting
Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma
Led by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. · Updated on 2026-02-27
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and tolerability of BAFF-R CAR-T Cells in Adult Subjects with CD19-Negative relapsed or refractory B-Cell Lymphoma.
CONDITIONS
Official Title
Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Diagnosed with CD19-negative relapsed or refractory B-cell lymphoma defined by failure or relapse criteria after specified lines of therapy
- Expected survival of at least 3 months
- BAFF-R expression detected on tumor cells by flow cytometry or immunohistochemistry
- ECOG performance status of 2 or less
- Adequate kidney function: serum creatinine ≤ 1.5 times upper limit of normal or eGFR ≥ 60 mL/min/1.73 m²
- Adequate liver function: ALT ≤ 5 times age-specific upper limit of normal and total bilirubin ≤ 2.0 mg/dL (exceptions apply for Gilbert-Meulengracht syndrome)
- Pulmonary reserve with oxygen saturation >95% on room air and ≤ Grade 1 dyspnea
- Stable heart function with left ventricular ejection fraction ≥ 45%
- Adequate bone marrow function without recent transfusion: ANC ≥ 1 x 10⁹/L, ALC ≥ 0.1 x 10⁹/L, platelets ≥ 50 x 10⁹/L, hemoglobin > 80 g/L
- General condition and biochemical values normal or sufficiently compensated to receive lymphodepletion and CAR-T therapy as judged by investigator
You will not qualify if you...
- Women who are pregnant, breastfeeding, or planning pregnancy within 6 months
- Presence of infectious diseases such as HIV or active tuberculosis
- Active infections including hepatitis B or hepatitis C
- Abnormal vital signs or refusal to undergo examinations
- Psychiatric or psychological disorders preventing treatment or assessment
- History of severe hypersensitivity or allergy to IL-2
- Severe systemic or local infections requiring antimicrobial treatment
- Significant dysfunction of vital organs (heart, lung, brain, kidney) or any other condition preventing enrollment as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Suzhou Hongci Hematology Hospital
Suzhou, China
Actively Recruiting
Research Team
X
Xiao Ma
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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