Actively Recruiting
CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease
Led by ShenZhen Cell Valley · Updated on 2025-09-26
3
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
S
ShenZhen Cell Valley
Lead Sponsor
F
First Hospital of China Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this study, CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19 to treat autoimmune disease. The CAR-T cells were provided by Shenzhen Cell Valley. A study published in the New England Journal of Medicine provides strong evidence for the therapeutic potential of CD19 CAR-T therapy in autoimmune diseases. The study enrolled 15 participants, including eight with severe SLE, three with idiopathic inflammatory myositis, and four with systemic sclerosis. The median follow-up was 15 months (4 to 29 months). Data from the clinical trial showed that all patients with SLE had a remission of DORIS, all patients with idiopathic inflammatory myositis had an ACR-EULAR major clinical response, all patients with systemic sclerosis had a decrease in the EUSTAR activity index score, and all patients discontinued immunosuppressive therapy completely. The investigators look forward to expanding the use of CAR-T cells in relapsed/refractory autoimmune diseases through this safety and efficacy clinical study and greatly enhancing the quality of life for these patients.
CONDITIONS
Official Title
CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years inclusive
- Positive CD19 expression in peripheral blood B cells confirmed by flow cytometry
- Adequate bone marrow function: white blood cell count 653�d7109/L, neutrophil count 651�d7109/L without recent colony-stimulating factor, hemoglobin 6560g/L
- Liver function within limits: ALT 653 times upper limit of normal (ULN) except inflammatory myopathy, AST 653 times ULN except inflammatory myopathy, total bilirubin 651.5 times ULN except Gilbert's syndrome
- Renal function with creatinine clearance 6530 ml/min (Cockcroft/Gault formula) except disease-related decline
- Coagulation within limits: INR 651.5 x ULN, prothrombin time 651.5 x ULN
- Stable cardiac function
- Female and male participants of childbearing potential must use contraception or be abstinent during and for 6 months after treatment; females of childbearing potential must have negative serum HCG test within 7 days prior to enrollment and not be breastfeeding
- Voluntary participation with signed informed consent, good compliance, and ability to follow up
- Diagnosed with relapsed refractory systemic lupus erythematosus meeting 2019 EULAR/ACR criteria, with specified disease activity scores and organ involvement
- Diagnosed with relapsing refractory/progressive diffuse systemic sclerosis meeting 2013 ACR criteria with relevant antibody positivity and disease manifestations
- Diagnosed with relapsed refractory/progressive inflammatory myopathy meeting 2017 EULAR/ACR criteria with antibody positivity and muscle involvement
- Diagnosed with relapsed refractory/progressive immune thrombocytopenia meeting 2019 ASH criteria, with bone marrow morphology and exclusion of secondary thrombocytopenia
- Definitions of relapse-refractory and progressive disease as specified in criteria
You will not qualify if you...
- History of severe drug allergies or sensitivities
- Uncontrolled or untreated fungal, bacterial, viral or other infections
- Central nervous system disorders caused by or unrelated to autoimmune diseases
- Intolerable cardiac function
- Congenital immunoglobulin defects
- History of malignant tumors within last five years
- End-stage renal failure
- Positive tests for hepatitis B surface antigen, hepatitis B core antibody with high HBV DNA, hepatitis C antibody with HCV RNA, HIV antibody, or syphilis
- Mental illness or severe cognitive impairment
- Participation in other clinical trials within 3 months prior to enrollment
- Use of immunosuppressants or biologics with therapeutic effect within five half-lives before enrollment
- Women who are pregnant or intend to become pregnant
- Any other reasons judged by the investigator to exclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
No. 155, The First Affiliated Hospital of China Medical University, Nanjing North Street, Heping District, Shenyang, Liaoning Province
Shenyang, Liaoning, China, 110001
Actively Recruiting
Research Team
R
rui sun
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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