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โ† Trials
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Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases

RecruitingPhase 1Ages 18 Years - anyAllKite, A Gilead Company
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 6 and QMG score โ‰ฅ 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.
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What it tests

  • anito-cel
  • Cyclophosphamide
  • Fludarabine
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Where

14 sites
Ronald Reagan UCLA Medical Center
Los Angeles, United States
UC Irvine Medical Center
Orange, United States
Stanford Blood and Marrow Transplant
Palo Alto, United States
Moffitt Cancer Center
Tampa, United States
University of South Florida - Carol and Frank Morsani Center for Advanced Healthcare
Tampa, United States
Karmanos Cancer Institute
Detroit, United States
University of Minnesota Delaware Clinical Research Unit
Minneapolis, United States
Mayo Clinic
Rochester, United States

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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