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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 10 Sep 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

  • 11 Jun 2025 Results from this study presented at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress.
  • 11 Jun 2025 According to a Fate Therapeutics media release, the company has reached agreement with US FDA to allow for clinical investigation of multiple B cell-mediated autoimmune diseases under this trial establishing the basis for conduct of a single Phase 1 basket study across autoimmune indications. The Company plans to initiate independent dose-expansion cohorts in each of anti-neutrophilic cytoplasmic antibody-associated vasculitis, idiopathic inflammatory myositis, and systemic sclerosis in H2 2025.
  • 11 Jun 2025 Results presented in the Fate Therapeutics Media Release.

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