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

RecruitingPhase 1

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: Arcellx, Inc. · Participants: 30 · Started: Apr 30, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06626919

Locations in the U.S.

CaliforniaUCLA Medical Center, Los Angeles
University of California, Irvine, Orange
Stanford Hospital, Palo Alto
FloridaUniversity of South Florida - Carol and Frank Morsani Center of Advanced Healthcare, Tampa
MichiganKarmanos Cancer Institute, Detroit
MinnesotaUniversity of Minnesota Delaware Clinical Research Unit, Minneapolis
Mayo Clinic, Rochester
New YorkColumbia University Irving Medical Center, New York
OhioOhio State University, Columbus
OregonOregon Health & Science University (OHSU), Portland
PennsylvaniaTemple University Hospital, Philadelphia
TexasUT Southwestern Medical Center, Dallas
Houston Methodist Hospital, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.