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

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

Age range

12–70 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  FT819

  FT819 will be administered as intravenous (IV) infusion at planned dose levels.

• Drug
  Fludarabine

  Fludarabine will be administered as an IV infusion at planned dose levels.

• Drug
  Cyclophosphamide

  Cyclophosphamide will be administered as an IV infusion at planned dose levels.

• Drug
  Bendamustine

  Bendamustine will be administered as an IV infusion at planned dose levels.

Locations (18)