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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: 13 Jun 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 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.
  • 28 May 2025 According to a Fate Therapeutics media release, company announced that clinical and preclinical data from the Companys off-the-shelf cell therapy product platform will be featured at the European Alliance of Associations for Rheumatology European Congress of Rheumatology (EULAR 2025), being held in Barcelona, Spain on June 11 to 14, 2025.

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