A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
Sponsor: Fate Therapeutics
Listed as NCT06308978, this observational or N/A phase trial focuses on Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV) and Idiopathic Inflammatory Myositis (IIM) and remains actively recruiting participants. Sponsored by Fate Therapeutics, it has been updated 12 times since 2024, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
12 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE1 → None
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Mar 2026 — May 2026 [monthly]
Recruiting PHASE1
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE1
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Dec 2025 — Feb 2026 [monthly]
Recruiting PHASE1
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Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE1
▶ Show 7 earlier versions
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Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE1
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE1
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Jul 2025 — Sep 2025 [monthly]
Recruiting PHASE1
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May 2025 — Jul 2025 [monthly]
Recruiting PHASE1
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Sep 2024 — May 2025 [monthly]
Recruiting PHASE1
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE1
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Apr 2024 — Jul 2024 [monthly]
Recruiting PHASE1
First recorded
Mar 2024
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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.
Contact Information
- Fate Therapeutics
For direct contact, visit the study record on ClinicalTrials.gov .