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

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 17 Apr 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

14 Apr 2025 According to a Fate Therapeutics media release, additional Phase 1 clinical data of FT819 to be presented at medical conferences in 2025
14 Apr 2025 According to a Fate Therapeutics media release, the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to FT819, RMAT review by FDA included initial clinical safety and activity data from ongoing Phase 1 study of FT819 in SLE.
10 Apr 2025 Arms increased from 1 to 5. Protocol amended with indications antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc).

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