Home › Muscle Disorders › NCT06626919
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
RecruitingPhase 1
Who can join
Ages 18 and older · All sexes
Full 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 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
About the study
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.
What is being tested
- anito-cel (biological)
- Standard Lymphodepletion regimen (drug)
Sponsor: Arcellx, Inc. · Participants: 30 · Started: Apr 30, 2025
Contact the study team
- Clinical Information · Phone: 240-327-0379
Official record on ClinicalTrials.gov — NCT06626919
Locations in the U.S.
Conditions
- Muscle Disorders
- Autoimmune Diseases
- Autoimmune Diseases of the Nervous System
- Myasthenia Gravis
- Muscle Weakness
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.