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

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.

Timeline

Start

2024-07-12

Primary completion

2025-11-01

Completion

2026-12-01

Publications

• Ruan Z, Ning F, Zhang W, Li S, Su Y, Tang Y, Cao X, Huang X, Song N, Li Z, Li H, Luan X, Yang N, Li Y, Paul F, Liu Q, Chang T. Single-cell profiling of immune reset in patients with refractory generalized myasthenia gravis receiving autologous CD19/BCMA CAR-T cell therapy. Med. 2026 Apr 10;7(4):101026. doi: 10.1016/j.medj.2026.101026. Epub 2026 Feb 25.

Drugs

Indications