NCT06308978

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

Recruiting now Phase 1 Last updated 9 March 2026

What this trial tests

Phase 1 trial testing FT819 in Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV) in 244 participants. Currently enrolling.

Timeline

28 March 2024

Primary endpoint
30 September 2027

30 September 2042

Quick facts

Lead sponsor	Fate Therapeutics
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	244
Start date	28 March 2024
Primary completion	30 September 2027
Estimated completion	30 September 2042
Sites	17 locations across France, United Kingdom, United States, Sweden

Drugs / interventions tested

• FT819 — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Bendamustine (BENDAMUSTINE) — full drug profile →

Conditions studied

• Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV) — all drugs for Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV) →
• Idiopathic Inflammatory Myositis (IIM) — all drugs for Idiopathic Inflammatory Myositis (IIM) →
• Systemic Sclerosis (SSc) — all drugs for Systemic Sclerosis (SSc) →
• Systemic Lupus Erythematosus (SLE) — all drugs for Systemic Lupus Erythematosus (SLE) →

Sponsor

Fate Therapeutics — full company profile →

Who can join

Adults 12 to 70, any sex, with Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV) or Idiopathic Inflammatory Myositis (IIM). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. From promise to practice: CAR T and Treg cell therapies in autoimmunity and other immune-mediated diseases.
   Bulliard Y, Freeborn R, Uyeda MJ, Humes D, et al · · 2024 · cited 19× · PMID 39697333 · DOI 10.3389/fimmu.2024.1509956
2. Advancing gene editing therapeutics: Clinical trials and innovative delivery systems across diverse diseases.
   Raigani M, Eftekhari Z, Adeli A, Kazemi-Lomedasht F. · · 2025 · cited 5× · PMID 40896588 · DOI 10.1016/j.omtn.2025.102666
3. Pluripotent stem cell-based immunotherapy: advances in translational research, cell differentiation, and gene modifications.
   Lei Q, Deng H, Sun S. · · 2025 · cited 3× · PMID 40110110 · DOI 10.1093/lifemedi/lnaf002
4. Innovations in immunotherapy for autoimmune diseases: recent breakthroughs and future directions.
   Alsayb MA. · · 2025 · cited 2× · PMID 41041324 · DOI 10.3389/fimmu.2025.1647066
5. Global clinical trials on stem cell therapy for autoimmune diseases: trends and future directions.
   Chen Y, Li X, Zhang J, Peng J, et al · · 2025 · cited 2× · PMID 40777013 · DOI 10.3389/fimmu.2025.1616231
6. Roads and detours for CAR T cell therapy in autoimmune diseases.
   Avouac J, Barzel A, Caiati D, Davis RS, et al · · 2026 · cited 1× · PMID 41588112 · DOI 10.1038/s41573-025-01349-4
7. Juvenile-onset Systemic Lupus Erythematosus: Recent Advances in Pathogenesis and Treatment.
   Natoli V, Charras A, Smith EM, Hedrich CM. · · 2025 · cited 1× · PMID 41410901 · DOI 10.1007/s11926-025-01207-7
8. Key considerations for advancing chimeric antigen receptor (CAR) T-cell therapy for systemic lupus erythematosus (SLE): a multi-partner/disciplinary working group perspective.
   Hsieh EWY, Chung JB, Amin A, Askanase AD, et al · · 2025 · cited 1× · PMID 41052891 · DOI 10.1136/rmdopen-2025-005866