Clinical Trial

CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease

Recruiting
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Summary
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.
Trial Details
NCT Number NCT07193667
Lead Sponsor ShenZhen Cell Valley
Collaborators: First Hospital of China Medical University
Conditions Relapsed/Refractory Autoimmune Diseases
Enrollment 3 participants
Start Date 2025-10
Primary Completion 2027-09 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-09-26