CABA-201 for Generalized Myasthenia Gravis

UCI Specialty Area: Neurology

Principal Investigator: Ali Habib

Official Title: A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Participants with Generalized Myasthenia Gravis

A Study On:

Myasthenia Gravis

Study Description

PRIMARY: To evaluate the safety and tolerability of CABA-201 in participants with generalized MG.

SECONDARY: To evaluate the safety and tolerability of CABA-201 in participants with generalized MG over 156 weeks, to evaluate the effects of CABA-201 on hematologic and immunologic parameters including WBCs and T, B, NK, and myeloid populations, to evaluate CABA-201 manufacturing success rates.

This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability, and efficacy of CABA-201 in adult participants with generalized MG. Any participant who receives CABA-201 will be followed after infusion for 156 weeks for safety and efficacy as outlined in the Schedule of Activities. Safety monitoring will continue in all treated participants via either the long-term

follow-up (LTFU) period as described in this protocol or in a separate LTFU study.

Eligibility

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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Future Research Use
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