Home › Muscle Disorders › NCT06626919
Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-Oncology Plasma Cell-Related Diseases
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- anito-cel (biological)
- Cyclophosphamide (drug)
- Fludarabine (drug)
Sponsor: Kite, A Gilead Company · Participants: 30 · Started: Apr 30, 2025
Contact the study team
- Medical Information · Phone: 844-454-5483(1-844-454-KITE)
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 Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.