GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis(24103)
An Early Exploratory Clinical Study of GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis
Daishi Tian
6 participants
Jul 15, 2025
INTERVENTIONAL
Conditions
Summary
This is a single-arm, open-label and early exploratory clinical study, with the purpose to study the safety, tolerability and initial clinical efficacy of GC012F Injection in the treatment of refractory GMG and to evaluate the PK, PD characteristics and immunogenicity in subjects with refractory GMG infused with GC012F Injection.
Eligibility
Plain Language Summary
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Interventions
Subjects will be infused with GC012F Injection within 48-72 hours after lymphodepletion pretreatment,the infusion doses will be (CAR-T cell count) 3 × 10\^5/kg. Note: for subjects weighing ≤70 kg: number of infused CAR-T cells = 3 (±20%) × 10\^5 × body weight(kg); for subjects weighing \>70 kg: number of infused CART cells (fixed doses of GC012F Injection) = 3 (±20%) × 10\^5 × 70 kg.
Locations(1)
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NCT07058298