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

NCT06958939 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-05-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hebei Senlang Biotechnology Co., LTD

    collaborator UNKNOWN

  • Ting Chang, MD

    lead OTHER

Principal Investigators

  • Ting Chang · The Second Affiliated Hospital of Air Force Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-03-31
Completion
2026-08-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06958939 on ClinicalTrials.gov