Actively Recruiting
Multicenter, Single-Arm Exploratory Phase I Clinical Study on the Safety and Efficacy of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Participants With 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
N/A
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
Researchers are studying the safety and best dose of BAFF-R Chimeric Antigen Receptor T-Cell Injection (BAFF-R CAR-T) in adults with relapsed or refractory BAFF-R-positive B-cell lymphoma. They are also exploring how well this treatment works and how it behaves in the body, including its effects on different immune cells. This is a phase I/II dose-escalation clinical trial designed to find the maximum tolerated dose and evaluate preliminary efficacy. Participants receive one of three doses of BAFF-R CAR-T cells, given as a single intravenous infusion after a chemotherapy preconditioning regimen with fludarabine and cyclophosphamide. The study follows a "3+3" dose escalation design with 14-day intervals between infusions in each dose group. After dose escalation, an expansion phase will enroll up to 20 participants at the selected optimal dose to further assess safety and effectiveness. Participants undergo a screening period, followed by blood collection for CAR-T cell preparation, which takes about 15 to 25 days. Before infusion, they receive chemotherapy to prepare the body. After the CAR-T infusion, they are monitored through physical exams, vital signs, lab tests, imaging, and treatment efficacy evaluations at set intervals up to 24 months. Researchers track safety outcomes and measure responses such as remission and survival rates during this follow-up.
CONDITIONS
Brief 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...
- Adults aged 18 to 75 years with no restriction on gender
- Confirmed diagnosis of relapsed or refractory BAFF-R-positive B-cell lymphoma according to NCCN guidelines
- Presence of at least one measurable lesion ≥ 1.5 cm or bone marrow involvement
- Prior treatment with at least two lines of therapy including anti-CD20 monoclonal antibody and relevant therapies depending on lymphoma subtype
- Expected survival time of at least 12 weeks
- Serum total bilirubin ≤ 37.2 µmol/L or ≤ 3.0 × ULN for Gilbert syndrome; ALT and AST < 2.5 × ULN; eGFR ≥ 30 ml/min/1.73m²
- ECOG performance status 0-1
- Left ventricular ejection fraction ≥ 50%; oxygen saturation > 91%
- Agreement to use effective contraception from consent until one year after infusion; negative pregnancy test for women of childbearing potential
- Ability and willingness to voluntarily participate and sign informed consent form
You will not qualify if you...
- History of allergy to any component of the cellular product
- Acute graft-versus-host disease Grade II-IV or recent systemic treatment for GVHD
- Live vaccine within 4 weeks prior to enrollment
- CNS diseases unrelated to lymphoma involvement
- Severe active infections or current intravenous antibiotic therapy (except certain uncomplicated infections)
- Positive for hepatitis B surface antigen or HBV DNA
- Positive for hepatitis C antibody and RNA
- Other immunodeficiency diseases including positive HIV, CMV DNA > 400 copies/mL, or positive syphilis test
- Heart failure NYHA Grade III or IV
- History of other primary malignancies except certain treated cancers with no recurrence for over 5 years
- History of solid organ transplantation
- Autoimmune diseases with abnormal cellular immunity or requiring immunosuppressive therapy
- Use of investigational drugs within 3 months prior to consent
- Pregnancy or breastfeeding
- Psychiatric disorders, consciousness disturbances, or CNS diseases
- Unresolved toxic effects from prior treatment above Grade 2 (except alopecia)
- Recent use of therapeutic-dose corticosteroids or systemic antineoplastic therapy without required washout
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo peripheral blood mononuclear cell (PBMC) apheresis to collect cells for preparation of BAFF-R CAR-T.
1 visit (in-person)
Duration - 3 days
Participants receive lymphodepleting chemotherapy preconditioning 4 to 2 days before BAFF-R CAR-T infusion and complete baseline assessments.
3 visits (in-person) over preconditioning days
Duration - 1 day
Participants receive a single intravenous dose of BAFF-R CAR-T after preconditioning. Medications to prevent allergic reactions are given 30 minutes before infusion.
1 infusion visit (in-person)
Duration - Up to 24 months
Participants are monitored for safety and efficacy through physical exams, vital signs, lab tests, imaging, and treatment response evaluations.
Multiple visits at Day 28, Month 2, Month 3, Month 6, Month 12, and Month 24 after treatment
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here