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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)
• Idiopathic Inflammatory Myositis (IIM)
• Systemic Sclerosis (SSc)
• Systemic Lupus Erythematosus (SLE)
• Lupus Nephritis

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1

Ages

12 to 70 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Fate Therapeutics

Last updated on ClinicalTrials.gov

May 22, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites