An Early Exploratory Clinical Study of GC012F Injection in the Treatment of Refractory Generalize… (NCT06759948) | Clinical Trial Compass
Not Yet RecruitingPhase 1
An Early Exploratory Clinical Study of GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis
China18 participantsStarted 2025-02-15
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 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;
✓. Ineffectiveness of conventional treatment and/or lack of effective therapeutic options, referring to relapse or exacerbation after standard treatments with hormones, immunosuppressants (e.g., azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, cyclophosphamide, methotrexate, etc.), or biological agents (e.g., rituximab);
✓. If the subject is currently using corticosteroids, the dose of prednisone must not exceed 30 mg/day (or the equivalent dose of other corticosteroids) and must remain stable for at least 4 weeks prior to infusion;
✓. Only subjects with positive MG-specific autoantibodies: the titer/level of anti-acetylcholine receptor (anti-AChR) antibodies or muscle-specific kinase (anti-MuSK) antibodies must be above the reference laboratory's upper normal limit (UNL);
✓. The results of laboratory test during screening period shall meet all following criteria:
Exclusion criteria
✕. Subjects have a history of severe hypersensitivity or allergy;
What they're measuring
1
Primary endpoints
Timeframe: Since signing the ICF until 24-week post-infusion or premature withdrawal from the study, whichever comes first.
2
Primary endpoints
Timeframe: Since signing the ICF until 24-week post-infusion or premature withdrawal from the study, whichever comes first.