clinical trial · NCT06308978
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)Idiopathic Inflammatory Myositis (IIM)Systemic Sclerosis (SSc)Systemic Lupus Erythematosus (SLE)FT819FludarabineCyclophosphamideBendamustine
brief summary
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), 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.
started
Mar 28, 2024
primary completion
Sep 30, 2027
completion
Sep 30, 2042
last updated
Mar 9, 2026
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol