Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory Generalized Myasthenia Gravis
Evaluate the Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory, Generalized Myasthenia Gravis: A Single-center, Open-label, Single-arm, Dose-finding Study
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
CD19-BCMA Targeted CAR-T Dose 1
5.0 e5/ kg CD19-BCMA CAR-T positive T cells
CD19-BCMA Targeted CAR-T Dose 2
1.5 e6/ kg CD19-BCMA CAR-T positive T cells
CD19-BCMA Targeted CAR-T Dose 2
5 e6/ kg CD19-BCMA CAR-T positive T cells