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
Interested in this trial?
Get notified about updates and connect with the research team.
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
For the most up-to-date information, visit the official listing.
NCT06626919
Related Trials
Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults
NCT069981341 location
Deciphering the Genetic Architecture of Autoimmune Diseases
NCT069481102 locations
Imaging Skeletal Muscle Mitochondrial OXPHOS Activity In Acute Lymphoblastic Leukemia Survivors
NCT068194751 location
Effect of Weight Loss on Intermuscular Adipose Tissue (IMAT) Signaling
NCT061291101 location
KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis
NCT0619388917 locations