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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

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Nov 20, 2025 to Feb 20, 2026v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07246096
Lead Sponsor Changhai Hospital
Collaborators: Rui Therapeutics Co., Ltd
Conditions
(from sponsor)		 Autoimmune Diseases, Systemic Lupus Erythematosus, Systemic Sclerosis, Primary Sjögren Syndrome, Rheumatoid Arthritis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Related terms Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Arthritis, Rheumatoid, Autoimmune Diseases, Lupus Erythematosus, Systemic, Scleroderma, Systemic
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov