A Phase 1 dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of anito-cel in subjects with generalized myasthenia gravis (GMG). Anitocabtagene autoleucel (anito-cel) is a BCMA-directed CAR-T cell therapy.
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Eligibility Criteria
Inclusion Criteria:
* Subject must be 18 years of age or older
* Must have MGFA clinical classification Grades 2-4A at time of screening
* Subject must have clinically active disease and requiring ongoing therapy for GMG
* MG-ADL score 6 and QMG score \>10 at screening
* GMG specific autoantibodies…
Inclusion Criteria:
* Subject must be 18 years of age or older
* Must have MGFA clinical classification Grades 2-4A at time of screening
* Subject must have clinically active disease and requiring ongoing therapy for GMG
* MG-ADL score 6 and QMG score \>10 at screening
* GMG specific autoantibodies must be above the reference laboratory ULN
Exclusion Criteria:
* Subject is pregnant or breastfeeding
* Treatment with Anti-CD20 agents, calcineurin inhibitors, FcRN inhibitors, azathioprine, mycophenolate mofetil, methotrexate, or cyclophosphamide within the specified time frame prior to leukapheresis or prior to anito-cel infusion
* Previous treatment with any gene therapy, chimeric antigen receptor therapy or T cell engager
* Previous thymectomy within 6 months of screening
* Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator
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