Actively Recruiting
An Exploratory Clinical Study of SCAR02 Targeting BCMA and CD19 for the Treatment of Refractory Autoimmune Diseases
Led by The First Affiliated Hospital of University of Science and Technology of China · Updated on 2025-04-24
18
Participants Needed
1
Research Sites
211 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
An Exploratory Clinical Study of SCAR02 Targeting BCMA and CD19 for the Treatment of Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Age 18 years or older, any gender.
- Bone marrow hematopoietic function with white blood cell count ≥3x10^9/L; neutrophil count ≥1x10^9/L (no colony-stimulating factor within 2 weeks before screening); hemoglobin ≥60g/L.
- Liver function: ALT ≤3 times upper limit of normal (ULN); AST ≤3 times ULN; total bilirubin ≤3 times ULN.
- Renal function: creatinine clearance (CrCl) ≥60 mL/min.
- Coagulation function: INR <1.5 times ULN, prothrombin time <1.5 times ULN.
- For rheumatoid arthritis: diagnosis per 2010 ACR/EULAR criteria; active disease despite standard treatments; stable use of 1 or 2 csDMARDs as specified.
- For systemic lupus erythematosus (SLE): diagnosis per 2019 EULAR/ACR criteria; active disease for at least 6 months; positive antibody tests; SLEDAI-2000 score ≥8.
- For dry syndrome: diagnosis per 2002 or 2016 criteria; platelet count <30 x 10^9/L; active disease despite conventional therapy.
- For systemic sclerosis: diagnosis per 2013 ACR criteria; positive antinuclear antibodies; evidence of disease progression; active disease despite conventional therapy.
You will not qualify if you...
- Clinically significant central nervous system diseases or damage unrelated to autoimmune disease.
- Serious heart diseases such as angina, myocardial infarction, heart failure, or arrhythmia.
- History of major organ or hematopoietic stem cell/bone marrow transplantation.
- Vaccination or B-cell targeted therapy within 4 weeks before screening.
- History of any malignant disease.
- End-stage renal failure.
- Uncontrolled fungal, bacterial, viral, or other infections.
- Severe allergy to study drugs or components such as cyclophosphamide, fludarabine, or DMSO.
- Positive tests for HBV, HCV, HIV, syphilis, CMV, or EBV infections.
- Pregnancy, breastfeeding, or plans for pregnancy within 2 years after treatment.
- Evidence of active tuberculosis infection.
- Any other conditions deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hunan Siweikang Therapeutic Co.Ltd
Changsha, Hunan, China, 410119
Actively Recruiting
Research Team
Z
zhu chen, M.D
CONTACT
X
xiaojuan zhao, master
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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