Clinical Trial

Safety and Efficacy of CD19 CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases

Recruiting
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Summary
This study is a single center, open label exploratory clinical trial aimed at evaluating the safety and efficacy of universal CD19 CAR-T therapy in subjects with autoimmune diseases. The study will adopt the traditional dose escalation model "3+3" design, setting up three dose groups with a starting dose of 0.5 × 106 CAR+T cells/kg for incremental DLT observation. Safety and efficacy follow-up will be conducted for 24 months after cell infusion to observe the safety of the universal CD19 CAR-T and conduct preliminary efficacy evaluation.
Trial Details
NCT Number NCT06983964
Lead Sponsor Beijing Boren Hospital
Conditions Autoimmune Disease
Enrollment 12 participants
Start Date 2025-02-20
Primary Completion 2027-02-20 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-21