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

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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

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