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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

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: 09 Dec 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

  • 10 Nov 2025 According to a Cabaletta Bio media release, data from this trial is expected in second half of 2026.
  • 07 Aug 2025 According to a Cabaletta Bio media release, additional regulatory discussions planned with FDA to align on additional registrational cohort designs for RESET-MG trial in 1H 2026.
  • 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.

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