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NCT07917923

A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Refractory Generalized Myasthenia Gravis

StatusNot Yet Recruiting
PhaseEarly Phase 1
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Adverse Events (AEs) occurring after infusion and their proportions
Timeframe: From infusion to at least 1 year

Secondary (8)

Quantitative Myasthenia Gravis (QMG) score
Myasthenia Gravis Activities of Daily Living (MG-ADL) score
Time to maximum amplification (Tmax)
Maximum amplification (Cmax)
Area under the curve (AUC)
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Duration of Detectable Concentration (Tlast)
Chimeric Antigen Receptor T cell (CAR-T)-associated serum cytokines
Anti-drug antibodies (ADA) Response to GT802 Measured by Immunoassay.

Arms and interventions

GT802 Injection treatment groupExperimental

Participants with MG administered GT802 Injection

Biologicals: GT802 Injection

Sites

1 site in 1 country

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, Hubei, China