Clinical Trial

Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases

Recruiting Early Phase 1
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Summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-20.
Trial Details
NCT Number NCT07246096
Lead Sponsor Changhai Hospital
Collaborators: Rui Therapeutics Co., Ltd
Conditions Autoimmune Diseases, Systemic Lupus Erythematosus, Systemic Sclerosis, Primary Sjögren Syndrome, Rheumatoid Arthritis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Enrollment 60 participants
Start Date 2026-02-20
Primary Completion 2027-07-20 (estimated)
Study Completion 2028-07-20 (estimated)
Updated on ClinicalTrials.gov 2026-02-25