What is anito-cel studying for generalized myasthenia gravis?

Anito-cel is being studied to evaluate its safety, tolerability, and initial effects in adults with generalized myasthenia gravis who need immunosuppressive treatment. Researchers want to understand the best dose and monitor how the therapy affects disease activity. This study is sponsored by Arcellx, Inc.

Who may be eligible for this generalized myasthenia gravis clinical trial?

Adults aged 18 and older with generalized myasthenia gravis classified as MGFA Grade 2 to 4a may be eligible. Participants must have active disease requiring ongoing therapy and specific symptom scores at screening. This trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this generalized myasthenia gravis clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID06626919

Phase 1 Study of Anitocabtagene Autoleucel CAR-T Therapy for Adults with Generalized Myasthenia Gravis

Led by Arcellx, Inc. · Updated on 2026-02-25

Participants Needed

Research Sites

56 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating anitocabtagene autoleucel anito-cel, a BCMA-directed CAR-T cell therapy, in adults with generalized myasthenia gravis GMG classified as MGFA Grade 2 to 4a. This Phase 1 open-label, multi-center study aims to assess the safety, tolerability, and preliminary efficacy of anito-cel in patients who require immunosuppressive therapy as determined by their neurologist. The study focuses on identifying dose-limiting toxicities DLTs, the maximum tolerated dose MTD, and selecting the recommended Phase 2 dose RP2D for treatment. The study includes sequential phases screening, enrollment with leukapheresis to collect cells, pretreatment with a standard lymphodepletion chemotherapy regimen for 5 days, and a single intravenous infusion of anito-cel cells. Optional bridging therapy may be given while the CAR-T cells are prepared. Following infusion, participants will be closely monitored for safety and efficacy outcomes over time. Participants will undergo safety monitoring for at least 28 days after infusion, with safety data collected throughout the study duration of up to 24 months. Clinical effects will be evaluated using measures including the Myasthenia Gravis Activities of Daily Living MG ADL score, Quantitative Myasthenia Gravis QMG score, and Myasthenia Gravis Composite MGC scale. Additionally, blood tests will monitor autoantibody levels and pharmacokinetics of the therapy. This comprehensive follow-up ensures careful assessment of treatment impact and participant health.

CONDITIONS

Brief Title

A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

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

You will not qualify if you...

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

Research Team

Clinical Information

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