Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06626919

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

Led by Arcellx, Inc. · Updated on 2026-02-25

30

Participants Needed

13

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

UCLA Medical Center

Los Angeles, California, United States, 90095

Actively Recruiting

2

University of California, Irvine

Orange, California, United States, 92602

Actively Recruiting

3

Stanford Hospital

Palo Alto, California, United States, 94305

Actively Recruiting

4

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

Tampa, Florida, United States, 33612

Actively Recruiting

5

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

6

University of Minnesota Delaware Clinical Research Unit

Minneapolis, Minnesota, United States, 55414

Actively Recruiting

7

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

8

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

9

Ohio State University

Columbus, Ohio, United States, 43221

Actively Recruiting

10

Oregon Health & Science University (OHSU)

Portland, Oregon, United States, 97239

Actively Recruiting

11

Temple University Hospital

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

12

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

13

Houston Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

C

Clinical Information

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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