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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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) 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.

Eligibility

Primary outcome measure(s)

• Number of participants with treatment-emergent adverse events (TEAEs) — Up to approximately 2 years
  The number of participants with TEAEs will be reported.
• Number of participants with serious TEAEs — Up to approximately 2 years
  The number of participants with serious TEAEs will be reported.
• Number of participants with dose-limiting toxicities (DLTs) — Up to approximately 29 days
  The number of participants with DLTs will be reported.

Trial sites (21)