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A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

Trial Profile

A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 18 Dec 2025

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At a glance

  • Drugs FT 819 (Primary) ; Bendamustine; Cyclophosphamide; Fludarabine
  • Indications Myositis; Systemic lupus erythematosus; Systemic scleroderma; Vasculitis
  • Focus Adverse reactions
  • Sponsors Fate Therapeutics

Most Recent Events

  • 08 Dec 2025 According to a Fate Therapeutics media release, data from the trial were presented at the 2025 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida.
  • 08 Dec 2025 Results presented in the Fate Therapeutics Media Release
  • 13 Nov 2025 According to a Fate Therapeutics media release, Fate Therapeutics has now received regulatory clearance from the United Kingdom (UK) MHRA to proceed with clinical evaluation of FT819 in autoimmune diseases. The first of several planned UK clinical sites is now active and open to patient enrollment. The Company also received regulatory authorization from the European Union (EU) EMA to initiate the FT819 clinical trial across multiple EU countries.

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