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.
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
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