Actively Recruiting
CAR-T Cells Therapy for Patients With Autoimmune Diseases
Led by Anhui Provincial Hospital · Updated on 2025-07-08
18
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART
CONDITIONS
Official Title
CAR-T Cells Therapy for Patients With Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years old at the time of signing the consent form
- Have adequate bone marrow function: white blood cell count ≥ 3 x 10^9/L, centrocyte count ≥ 1 x 10^9/L (no colony-stimulating factor within 2 weeks), hemoglobin ≥ 60 g/L
- Liver function within limits: ALT ≤ 3 times upper limit normal, AST ≤ 3 times upper limit normal, total bilirubin ≤ 3 times upper limit normal
- Kidney function with creatinine clearance ≥ 30 mL/min
- Blood clotting parameters: INR ≤ 1.5 times upper limit normal, PT ≤ 1.5 times upper limit normal
- For rheumatoid arthritis: documented diagnosis meeting 2010 ACR/EULAR criteria with active disease after standard treatments; stable use of certain disease-modifying drugs for specified durations
- For systemic lupus erythematosus: diagnosis per 2019 EULAR/ACR criteria, active disease with specific antibody positivity and disease activity scores
- For Sjögren's syndrome: diagnosis per classification criteria, active disease with platelet count < 30 x 10^9/L, stable use of immunomodulatory drugs for over 6 months
- For systemic sclerosis: diagnosis per 2013 ACR criteria, positive antinuclear antibody, evidence of lung progression, active disease after conventional treatments for at least 6 months
You will not qualify if you...
- Significant central nervous system diseases or brain disorders unrelated to autoimmune disease
- Serious heart conditions such as angina, heart attack, heart failure, or arrhythmia
- History of major organ or hematopoietic stem cell/bone marrow transplantation
- Vaccination or B-cell targeted therapy within 4 weeks prior to screening
- History of any cancer
- End-stage kidney failure
- Uncontrollable infections including fungal, bacterial, viral, or others
- Severe allergies to study drugs or their components
- Active infections with HBV, HCV, HIV, syphilis, CMV, or EBV
- Pregnant or breastfeeding women, or those planning pregnancy within 2 years after treatment; male partners planning pregnancy within 2 years
- Evidence of active tuberculosis
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Anhui Provincial Hospital
Hefei, China
Actively Recruiting
Research Team
C
chen zhu, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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