NCT06958939

The Safety and Efficacy of S103 in the Treatment of Refractory Generalized Myasthenia Gravis

A Single-center, Single-arm, Dose-exploration Study Evaluating the Safety and Efficacy of SENL103 Autologous T-cell Injection (S103) in the Treatment of Refractory Generalized Myasthenia Gravis

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 BCMA CAR-T（S103） in the treatment of refractory, generalized myasthenia gravis. The study is a dose escalation trial in adult, refractory, systemic MG patients. A total of 6-24 MG patients who meet the inclusion criteria are expected to be recruited.

Conditions

• Myasthenia Gravis, Generalized

Interventions

Type	Name	Description
DRUG	Dose level 1 group	1.0 × 10e6/kg S103 CAR-T cells
DRUG	Dose level 2 group	2.0 × 10e6/kg S103 CAR-T cells
DRUG	Dose level 3 group	4.0 × 10e6/kg S103 CAR-T cells
DRUG	Dose level 4 group	8.0 × 10e6/kg S103 CAR-T cells

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-03-31
• Completion: 2026-08-30
• First posted: 2025-05-06
• Last updated: 2025-05-06

Locations

1 site across 1 country: China