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.
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Number of participants with treatment-emergent adverse events (TEAEs)
Timeframe: Up to approximately 2 years
Number of participants with serious TEAEs
Timeframe: Up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)
Timeframe: Up to approximately 29 days