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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (13 locations)

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

A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases | DecenTrialz