Treatment of generalized myasthenia gravis with a new CAR-T therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 open-label, multi-center study evaluates the safety, tolerability, and preliminary efficacy of anitocabtagene autoleucel (anito-cel) in adults with generalized myasthenia gravis (GMG). Participants will undergo leukapheresis followed by lymphodepletion chemotherapy and a single infusion of anito-cel. The study aims to identify the maximum tolerated dose and assess any dose-limiting toxicities within the first 28 days post-infusion. Safety data will be collected throughout the study to support further development of this CAR-T cell therapy.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Individuals must be 18 years of age or older
* Must have Myasthenia Gravis Foundation of America (MGFA) clinical classification Grades 2-4A at time of screening
* Participant must have clinically active disease and requiring ongoing therapy for Generalized Myasthenia Gravis (GMG)
* MG-ADL score ≥ 6 and QMG score ≥ 10 at screening
* GMG specific autoantibodies must be above the reference laboratory upper limit of normal (ULN)

Key Exclusion Criteria:

* Individual 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• Ronald Reagan UCLA Medical Center
  Los Angeles, California, United States Recruiting
• UC Irvine Medical Center
  Orange, California, United States Recruiting
• Stanford Blood and Marrow Transplant
  Palo Alto, California, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• University of South Florida - Carol and Frank Morsani Center for Advanced Healthcare
  Tampa, Florida, United States Recruiting
• Karmanos Cancer Institute
  Detroit, Michigan, United States Recruiting

Study contacts

• Study coordinator: Medical Information
• Email: medinfo@kitepharma.com
• Phone: 844-454-5483(1-844-454-KITE)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.