Recruiting
Phase 1

Anitocabtagene Autoleucel

Sponsor:

Arcellx, Inc.

Code:

NCT06626919

Conditions

Muscular Diseases

Neuromuscular Manifestations

Autoimmune

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

anito-cel

Standard Lymphodepletion regimen

Study Details

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 (anito-cel) is a BCMA-directed CAR-T cell therapy.

Conditions

Muscular Diseases

Neuromuscular Manifestations

Autoimmune

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Study ID

NCT06626919

Start date

Apr 30, 2025

Status verified date

Feb, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: anito-cel

Single dose of anito-cel cells infused intravenously

Interventions

anito-cel

Anitocabtagene autoleucel BCMA directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-Domain

Standard Lymphodepletion regimen

Standard lymphodepletion regimen subject receive 5 days prior to CAR T infusion

Primary outcome measure

  • Assess safety profile, including any DLT and MTD (if applicable) [ Time Frame: 24 months ]
  • Selection of RP2D [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Clinical Information

240-327-0379clinical@arcellx.com

Locations

UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

University of California, Irvine

Recruiting

Orange, California, United States, 92602

Stanford Hospital

Recruiting

Palo Alto, California, United States, 94305

University of South Florida - Carol and Frank Morsani Center of Advanced Healthcare

Recruiting

Tampa, Florida, United States, 33612

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

University of Minnesota Delaware Clinical Research Unit

Recruiting

Minneapolis, Minnesota, United States, 55414

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Ohio State University

Recruiting

Columbus, Ohio, United States, 43221

Oregon Health & Science University (OHSU)

Recruiting

Portland, Oregon, United States, 97239

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Arcellx, Inc.

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • ARC-311
  • CART
  • CAR-T
  • BCMA
  • Anito-cel
  • Generalized Myasthenia Gravis
  • gMG
  • MG
  • Myasthenia Gravis
  • non-oncology plasma cell
  • autoimmune
  • auto-antibody
  • chimeric antigen receptor
  • D-Domain chimeric antigen receptor
  • B-cell maturation antigen (BCMA)
  • anitocabtagene autoleucel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arcellx, Inc. on 2026-02-25.