NCT06371040

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Ting Chang, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	CD19-BCMA Targeted CAR-T Dose 1	5.0 e5/ kg CD19-BCMA CAR-T positive T cells
DRUG	CD19-BCMA Targeted CAR-T Dose 2	1.5 e6/ kg CD19-BCMA CAR-T positive T cells
DRUG	CD19-BCMA Targeted CAR-T Dose 2	5 e6/ kg CD19-BCMA CAR-T positive T cells

Timeline

• Start date: 2024-07-12
• Primary completion: 2025-11-01
• Completion: 2026-12-01
• First posted: 2024-04-17
• Last updated: 2025-09-15

Locations

1 site across 1 country: China