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RESET-MG: 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

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Trial Profile

RESET-MG: 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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 08 Apr 2025

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At a glance

  • Drugs Resecabtagene autoleucel (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Myasthenia gravis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms RESET-MG
  • Sponsors Cabaletta Bio

    • Most Recent Events

    • 13 Jan 2025 As of December 31, 2024, 21 patients have been enrolled across 44 actively recruiting clinical sites in the U.S. and Europe across the RESET clinical development program.
    • 11 Dec 2024 Planned initiation date changed from 1 Oct 2024 to 1 Dec 2024.
    • 14 Nov 2024 According to a Cabaletta Bio media release, initial clinical data from the trial are expected in the first half of 2025. and this trial is not currently dosing patients as company is evaluate clinical and translational data from the first two cohorts.

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