An Early Exploratory Clinical Study of GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

February 15, 2025

Primary Completion Date

February 13, 2027

Study Completion Date

September 10, 2027

Conditions
Generalized Myasthenia Gravis (gMG)
Interventions
DRUG

GC012F injection

"Subjects will be infused with GC012F Injection within 48-72 hours after lymphodepletion pretreatment, the infusion dose (CAR-T cells) and groups are as follows:~1. Dose group 1: 1 × 10\^5/kg;~2. Dose group 2: 2 × 10\^5/kg;~3. Dose group 3: 3 × 10\^5/kg; Note: For subjects weighing ≤70 kg: number of infused CAR-T cells = (1, 2 or 3) (±20%) × 10\^5 × body weight(kg); for subjects weighing \>70 kg: number of infused CAR-T cells (fixed doses of GC012F Injection) = (1, 2 or 3) (±20%) × 10\^5 × 70 kg."

Trial Locations (1)

Unknown

Huashan Hospital, affiliated to Fudan University, Shanghai,, Shanghai

All Listed Sponsors
collaborator

Gracell Biotechnologies (Shanghai) Co., Ltd.

INDUSTRY

lead

Chongbo Zhao

OTHER

NCT06759948 - An Early Exploratory Clinical Study of GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis | Biotech Hunter | Biotech Hunter