Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases

About

Brief Summary

The goal of this clinical study is to learn more about the study drug Anitocabtagene autoleucel (anito-cel), and its safety, tolerability, dosing, and preliminary effectiveness in participants with generalized myasthenia gravis (GMG). Anito-cel is a B-cell maturation antigen (BCMA)-directed CAR-T cell therapy.

The primary objective of this study is to assess the safety profile, including any dose-limiting toxicity (DLT) and identification of a maximum tolerated dose (MTD) (if applicable), to support selection of the recommended Phase 2 dose (RP2D) of anito-cel when administered to participants with GMG.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Key Inclusion Criteria:

Individuals must be 18 years of age or older
Must have Myasthenia Gravis Foundation of America (MGFA) clinical classification Grades 2-4A at time of screening
Participant must have clinically active disease and requiring ongoing therapy for Generalized Myasthenia Gravis (GMG)
MG-ADL score ≥ 6 and QMG score ≥ 10 at screening
GMG specific autoantibodies must be above the reference laboratory upper limit of normal (ULN)

Key Exclusion Criteria:

Individual 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