Actively Recruiting
Safety and Efficacy of BAFF-R CART for Refractory Neuroimmune Diseases
Led by Tianjin Medical University General Hospital · Updated on 2025-06-15
27
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a phase Ib/IIa dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of autologous T cells expressing chimeric antigen receptor (CAR)-targeted B-cell activating factor receptor (BAFFR) in refractory neuroimmune diseases. The study design is divided into two parts, the first of which will be given to each patient at 3 incremental dose levels to establish the maximum tolerated dose (MTD). Each disease is expected to enroll 12 patients who meet the inclusion criteria. In the second part, 15 patients per disease will be recruited to further characterize the efficacy of the MTD.
CONDITIONS
Official Title
Safety and Efficacy of BAFF-R CART for Refractory Neuroimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with a refractory neuroimmune disease as assessed by the investigator
- Poor symptom control despite using at least three immunosuppressive agents for over one year
- Experienced at least two relapses within 12 months or three relapses within 24 months with one relapse within 12 months before screening
- Male participants must agree to use contraception during treatment and for one year afterward; sperm donation is prohibited
- Female participants with childbearing potential must agree to use contraception during treatment and for at least one year after treatment
- Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first treatment
You will not qualify if you...
- Any medical or psychiatric condition that may put the participant at risk or affect their participation
- History of drug or alcohol abuse within 12 months before baseline or any condition linked to poor adherence
- Women who are pregnant, breastfeeding, or planning pregnancy within 12 months after treatment, or had abortion within 4 weeks before screening
- Active or serious infections within 4 weeks before baseline
- Received live attenuated vaccine within 8 weeks before baseline or scheduled for one within 8 weeks after treatment
- Prior rituximab treatment within 6 months before baseline
- Prior tolizumab or eculizumab treatment within 3 months before baseline
- Prior intravenous immunoglobulin, plasma exchange, or immunotherapy within 4 weeks before baseline
- Serious underlying diseases like severe liver or kidney problems, blood disorders, severe heart disease, uncontrolled hypertension or diabetes
- Comorbid mental illness or recent suicidal ideation or attempts
- Abnormal lab results during screening (e.g., elevated liver enzymes, low kidney function, low CD19+ B cell count)
- History or high risk of tuberculosis infection
- Known immunodeficiency diseases including HIV infection
- Positive hepatitis B surface antigen during screening
- Blood transfusion therapy within 4 weeks before baseline or during screening
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
Research Team
Q
Qiang Liu, M.D.,Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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