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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 Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

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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 Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 18 Jul 2025

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At a glance

  • Drugs Resecabtagene autoleucel (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Autoimmune disorders; Dermatomyositis; Immune-mediated necrotising myopathy; Myositis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms RESET-Myositis
  • Sponsors Cabaletta Bio

Most Recent Events

  • 11 Jun 2025 According to a Cabaletta Bio media release, new clinical and translational data from RESET-Myositis, RESET-SLE and RESET-SSc trials evaluating rese-cel study being presented in three oral presentations at the ongoing European Alliance of Associations for Rheumatology (EULAR) 2025 Congress, which is being held from June 11-14, 2025, in Barcelona, Spain.
  • 11 Jun 2025 Results(data cut-off dates of May 6, 2025,n=7) presented in the Cabaletta Bio media release .
  • 15 May 2025 According to a Cabaletta Bio media release, following a Type C meeting with the FDA and receipt of meeting minutes in April 2025, company is planning to implement the design for two single-arm, disease-specific registrational cohorts in the ongoing RESET-Myositis trial, either of which, if successful, enable a future Biologics License Application (BLA) submission for rese-cel in myositis.

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