Status:
RECRUITING
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases
Lead Sponsor:
Arcellx, Inc.
Conditions:
Muscular Diseases
Neuromuscular Manifestations
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 (an...
Detailed Description
This is a Phase 1 open-label, multi-center safety and dose-escalation study of anito-cel\* in adult subjects with GMG (MGFA Grade 2 to 4a), in whom immunosuppressive therapy is clinically indicated in...
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06626919
Start Date
April 30 2025
End Date
April 1 2028
Last Update
February 25 2026
Active Locations (13)
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1
UCLA Medical Center
Los Angeles, California, United States, 90095
2
University of California, Irvine
Orange, California, United States, 92602
3
Stanford Hospital
Palo Alto, California, United States, 94305
4
University of South Florida - Carol and Frank Morsani Center of Advanced Healthcare
Tampa, Florida, United States, 33612