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

Description

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, Myasthenia Gravis, Muscle Weakness

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Muscular Diseases
Intervention / Treatment

-

Contacts and Locations

Orange

University of California, Irvine, Orange, California, United States, 92602

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arcellx, Inc.,

Study Record Dates

2028-04