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

Launched by ARCELLX, INC. · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called anitocabtagene autoleucel (or anito-cel) for people with a condition known as generalized myasthenia gravis (GMG), which causes muscle weakness. The goal of the study is to find out if this treatment is safe, how well it works, and how it can help improve the lives of those experiencing symptoms of this disease. The trial is currently looking for participants who are 18 years or older and have specific clinical signs of active GMG.

To be eligible for the study, participants must have certain scores indicating the severity of their condition and must still need treatment for their GMG. However, there are some criteria that would exclude someone from participating, such as being pregnant or having received certain other treatments recently. Participants can expect close monitoring throughout the study to track their health and any effects of the treatment. This trial represents a promising step toward better options for managing GMG and improving the quality of life for those affected by this challenging condition.

Gender

ALL

Eligibility criteria

• 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