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.
Subjects or their legal representative voluntary signing the ICF, and willing and able to follow the procedure in this study.
Aged between 18 and 75 years old (including 75), no gender limitation;
Patients with confirmed refractory GMG, and the clinical classification according to MGFA is IIa-IVb (including IIa, IIb, IIIa, IIIb, IVa and IVb) at screening;
At screening, the MG-ADL score must be ≥6, with ocular symptoms accounting for less than 50% of the total score, and QMG must be ≥11;
Subjects have a history of severe hypersensitivity or allergy;
Any contraindication for fludarabine, cyclophosphamide and any component of the investigational product;
Administration of intravenous immunoglobulin or plasmapheresis or immunoadsorption treatment within 4 weeks prior to infusion;
Use of B-cell targeting drugs, including but not limited to rituximab, Belimumab, and Telitacicept, within 6 months prior to apheresis;
Chongbo Zhao
Lead sponsor
Huashan Hospital
Sponsor institution
Gracell Biotechnologies (Shanghai) Co., Ltd.
Collaborator