A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Recruiting now · Phase 1
Conditions studied: Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE), Lupus Nephritis
In brief
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.
Key facts
- Study ID
- NCT06308978
- Run by
- Fate Therapeutics
- People needed
- 244
- Starts
- 2024-03-28
- Expected to finish
- 2042-09-30
- Last updated by the study team
- 2026-05-22
Who can join
Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Wallace Rheumatic Center — Beverly Hills, California, United States (enrolling)
- Providence Medical Foundation — Fullerton, California, United States (enrolling)
- University of California Irvine — Irvine, California, United States (enrolling)
- Children's Hospital Los Angeles Division Of Rheumatology — Los Angeles, California, United States (enrolling)
- University of California San Francisco — San Francisco, California, United States (enrolling)
- University of Florida — Gainesville, Florida, United States (enrolling)
- Nicklaus Children's Hospital — Miami, Florida, United States (enrolling)
- University of Louisville — Louisville, Kentucky, United States (enrolling)
- University of Minnesota Medical School — Minneapolis, Minnesota, United States (enrolling)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
- Montefiore Medical Center — New York, New York, United States (enrolling)
- Duke University Health System — Durham, North Carolina, United States (enrolling)
- MetroHealth — Cleveland, Ohio, United States (enrolling)
- University of Oklahoma — Oklahoma City, Oklahoma, United States (enrolling)
- Jefferson Einstein Hospital Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- Regional One Health — Memphis, Tennessee, United States (enrolling)
- Hôpital La Pitié Salpêtrière — Paris, France (enrolling)
- Uppsala University — Uppsala, Uppland, Sweden (enrolling)
- Manchester University NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (enrolling)
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (enrolling)
- University College of London Hospitals NHS Trust (UCLH) — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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