RecruitingAntineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)Idiopathic Inflammatory Myositis (IIM)Systemic Sclerosis (SSc)

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

Eligible age

12–70 yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.

Sponsor: Fate Therapeutics