A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncolo
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.
| Condition(s) | Muscular Diseases, Neuromuscular Manifestations, Autoimmune, Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Myasthenia Gravis, Muscle Weakness |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 il |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Arcellx, Inc. |
| Locations | Los Angeles, California, United States; Orange, California, United States; Palo Alto, California, United States; Tampa, Florida, United States; Detroit, Michigan, United States; Minneapolis, Minnesota, United States (+7 more sites) |
| Start date | 2025-04-30 |
| NCT ID | NCT06626919 |
| Official listing | https://clinicaltrials.gov/study/NCT06626919 |