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

RECRUITINGPhase 1Sponsored by Arcellx, Inc.
Actively Recruiting
PhasePhase 1
SponsorArcellx, Inc.
Started2025-04-30
Est. completion2027-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites
View on ClinicalTrials.gov →

NCT06626919

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions8

AutoimmuneAutoimmune DiseasesAutoimmune Diseases of the Nervous SystemCancerMuscle WeaknessMuscular DiseasesMyasthenia GravisNeuromuscular Manifestations

Locations13 sites

UCLA Medical Center
Los Angeles, California, 90095
University of California, Irvine
Orange, California, 92602
Stanford Hospital
Palo Alto, California, 94305
University of South Florida - Carol and Frank Morsani Center of Advanced Healthcare
Tampa, Florida, 33612
Karmanos Cancer Institute
Detroit, Michigan, 48201

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