Trials / Recruiting
RecruitingNCT06308978
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 244 (estimated)
- Sponsor
- Fate Therapeutics · Industry
- Sex
- All
- Age
- 12 Years – 70 Years
- Healthy volunteers
- Not accepted
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), 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.
Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)
- Idiopathic Inflammatory Myositis (IIM)
- Systemic Sclerosis (SSc)
- Systemic Lupus Erythematosus (SLE)
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-03-28
- Primary completion
- 2027-09-30
- Completion
- 2042-09-30
- First posted
- 2024-03-13
- Last updated
- 2026-03-09
Locations
17 sites across 4 countries: United States, France, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06308978. Inclusion in this directory is not an endorsement.