RecruitingPhase 1NCT06626919
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
Sponsor
Arcellx, Inc.
Enrollment
30 participants
Start Date
Apr 30, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A Phase 1 dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of anito-cel in subjects with generalized myasthenia gravis (GMG). Anitocabtagene autoleucel (anito-cel) is a BCMA-directed CAR-T cell therapy.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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
Exclusion Criteria5
- 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
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Interventions
BIOLOGICALanito-cel
Anitocabtagene autoleucel BCMA directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-Domain
DRUGStandard Lymphodepletion regimen
Standard lymphodepletion regimen subject receive 5 days prior to CAR T infusion
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT06626919
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