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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 Subjects With Systemic Sclerosis

Trial Profile

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 Subjects With Systemic Sclerosis

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 May 2025

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At a glance

  • Drugs Resecabtagene autoleucel (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Systemic scleroderma
  • Focus Adverse reactions
  • Acronyms RESET-SSc
  • Sponsors Cabaletta Bio

Most Recent Events

  • 15 May 2025 According to a Cabaletta Bio media release, systemic sclerosis registrational discussions with FDA anticipated in 4Q 2025.
  • 31 Mar 2025 According to a Cabaletta Bio media release, data from this study will be presented at the upcoming EULAR 2025 Congress, which is being held at Fira de Barcelona in Barcelona, Spain from June 11-14, 2025.
  • 31 Mar 2025 According to a Cabaletta Bio media release, in March 2025, Cabaletta learned of an important protocol deviation in the RESET-SSc trial.

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