A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Fludarabine
Fludarabine will be administered as an IV infusion at planned dose levels.
Cyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Bendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.