Tests anito-cel, a cell therapy, in adults with generalized myasthenia gravis
Tests anito-cel, a CAR-T cell therapy, in adults with generalized myasthenia gravis.
Plain-language title generated from the registry record
Registry title: Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases
Key facts
- Where
- Columbus, Dallas, Detroit, Houston, Los Angeles, Minneapolis, New York, Orange, Palo Alto, Philadelphia, Portland, Rochester, and Tampa, United StatesSee the 14 sites
- Phase
- Phase 1
Where in United States
- The Ohio State University -Wexner Medical CenterColumbus, United StatesTaking people
- UT Southwestern Medical CenterDallas, United StatesTaking people
- Karmanos Cancer InstituteDetroit, United StatesTaking people
- Houston Methodist HospitalHouston, United StatesTaking people
- Ronald Reagan UCLA Medical CenterLos Angeles, United StatesTaking people
- University of Minnesota Delaware Clinical Research UnitMinneapolis, United StatesTaking people
- Columbia University Irving Medical CenterNew York, United StatesTaking people
- UC Irvine Medical CenterOrange, United StatesTaking people
- Stanford Blood and Marrow TransplantPalo Alto, United StatesTaking people
- Lewis Katz School of Medicine at Temple UniversityPhiladelphia, United StatesTaking people
- Oregon Health Science UniversityPortland, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesTaking people
- University of South Florida - Carol and Frank Morsani Center for Advanced HealthcareTampa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kite, A Gilead Company
- Trial code
- NCT06626919
- Record updated
- 22 October 2026
- Original description
The goal of this clinical study is to learn more about the study drug Anitocabtagene autoleucel (anito-cel), and its safety, tolerability, dosing, and preliminary effectiveness in participants with generalized myasthenia gravis (GMG). Anito-cel is a B-cell maturation antigen (BCMA)-directed CAR-T cell therapy.Read full original descriptionShow less
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-Oncology Plasma Cell-Related Diseases
The goal of this clinical study is to learn more about the study drug Anitocabtagene autoleucel (anito-cel), and its safety, tolerability, dosing, and preliminary effectiveness in participants with generalized myasthenia gravis (GMG). Anito-cel is a B-cell maturation antigen (BCMA)-directed CAR-T cell therapy.
The primary objective of this study is to assess the safety profile, including any dose-limiting toxicity (DLT) and identification of a maximum tolerated dose (MTD) (if applicable), to support selection of the recommended Phase 2 dose (RP2D) of anito-cel when administered to participants with GMG.
Inclusion: 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).
Exclusion: 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; Individual is pregnant or breastfeeding.