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

StatusWithdrawn
PhaseNot applicable
Started

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Record History

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  1. Trial status changed: Recruiting → Withdrawn Sponsor's reason: No participants. Show 4 more changesShow less
    • Enrollment target: estimated 12 to confirmed 0
    • Primary completion date changed from estimate of Feb 20, 2027 to Apr 30, 2026
    • Eligibility criteria expanded, about 63 words
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
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
(from sponsor)		 Autoimmune Disease
Related terms Autoimmune Diseases
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov