GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis(24103) (NCT07058298) | Clinical Trial Compass
RecruitingEarly Phase 1
GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis(24103)
China6 participantsStarted 2025-07-15
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subjects or their legal representatives voluntarily sign a written informed consent and are willing and able to comply with the procedures of the study;
✓. Subjects aged 18-75 years old (both inclusive), male or female;
✓. Subjects with confirmed refractory gMG of classes IIa - IVb by MGFA clinical classification (including classes IIa, IIb, IIIa, IIIb, IVa and IVb) at screening;
✓. Subjects with the Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of ≥6, the proportion of ocular symptoms of \<50% of the total score, and the Quantitative Myasthenia Gravis (QMG) score of ≥11;
✓. Subjects with poor response and/or who do not respond to the conventional therapies, that means subjects who are still at risk of relapse or exacerbation after conventional therapies with hormones, immunosuppressants (e.g., azathioprine, mycophenolate mofetil, tacrolimus, cyclosporin A, cyclophosphamide, methotrexate, etc.), or biological agents (e.g., rituximab);
✓. For patients who are taking corticosteroids, the dose of prednisone should not exceed 30 mg/day (or an equivalent dose of other corticosteroids), and the dose must be stable for at least 4 weeks before infusion;
✓. The laboratory test results during the screening period meet the following criteria: