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

Recruiting now · Phase 1

Conditions studied: Muscular Diseases, Neuromuscular Manifestations, Autoimmune, Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Myasthenia Gravis, Muscle Weakness

In brief

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.

Key facts

Study ID

NCT06626919

Run by

Arcellx, Inc.

People needed

30

Starts

2025-04-30

Expected to finish

2028-04-01

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Medical Center — Los Angeles, California, United States (enrolling)
• University of California, Irvine — Orange, California, United States (enrolling)
• Stanford Hospital — Palo Alto, California, United States (enrolling)
• University of South Florida - Carol and Frank Morsani Center of Advanced Healthcare — Tampa, Florida, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• University of Minnesota Delaware Clinical Research Unit — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• Oregon Health & Science University (OHSU) — Portland, Oregon, United States (enrolling)
• Temple University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Houston Methodist Hospital — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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