Clinical Trial

Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory Generalized Myasthenia Gravis

Recruiting Phase 1
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Record status
This record was last updated September 15, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study is a single-center, open-label, single-arm, dose-exploration study to evaluate the safety and preliminary effectiveness of CD19-BCMA CAR-T in the treatment of refractory, generalized myasthenia gravis. The study is a dose escalation trial in adult, refractory, systemic MG patients. The Keyboard method will be used to perform dose escalation to explore the maximum tolerated dose (MTD). A total of 12 MG patients who meet the inclusion criteria are expected to be recruited.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-04-14; most recent amendment 2025-09-08.
Status change: Not Yet Recruiting → Recruiting 2024-08-20
Trial Details
NCT Number NCT06371040
Lead Sponsor Ting Chang, MD
Conditions Myasthenia Gravis
Enrollment 9 participants
Start Date 2024-07-12
Primary Completion 2025-11-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-15