GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis(24103)
ConditionGeneralized Myasthenia Gravis (gMG)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDaishi Tian
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
Have a history of severe hypersensitivity or allergy;
Contraindications or hypersensitivity to fludarabine, cyclophosphamide and any component of the test drug;
Subjects who have received intravenous immunoglobulin or plasma exchange therapy or immunoadsorption therapy within 4 weeks prior to infusion;
Received CD20-targeted drugs within 6 months prior to apheresis;
Trial design
Treatments tested in this trial
- GC012F injection
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Daishi Tian
Lead sponsor
Tongji Hospital
Sponsor institution
Gracell Biotechnologies (Shanghai) Co., Ltd.
Collaborator
Source ClinicalTrials.gov