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FT839 in Autoimmune Diseases
An Open-Label, Multicenter, Phase 1/2 Dose-Escalation and Expansion Trial Evaluating the Safety and Efficacy of FT839 in Participants With Autoimmune Diseases
Who can join
Ages 18 to 70 · All sexes
Full eligibility criteria
Inclusion Criteria: * Age ≥18 to ≤70 years * Must have active B-cell mediated autoimmune disease (AAV, IIM, RA, SLE, or SSc) confirmed by standard criteria * Moderate to severe disease, requiring at least two prior treatments that were ineffective * Adequate organ function to tolerate treatment * Able to provide informed consent and comply with study procedures Exclusion Criteria: * Diagnosis of more than 1 disease under study (AAV, IIM, RA, SSc, or SLE) or overlap syndrome * Women must not be pregnant or nursing * Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment. * Active or chronic infections * Active or recent malignancies * Prior CAR T-cell therapy or organ transplantation * Known allergies to study treatments * Body weight \<45 kg * Active central nervous system (CNS) symptoms attributable to autoimmune disease or nonmalignant CNS disease within 12 months prior to trial intervention * Receipt of any anti-CD19- or anti-CD20-directed therapy within 6 months prior to trial intervention
About the study
The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or conditioning therapy.
What is being tested
- FT839 (biological)
Sponsor: Fate Therapeutics · Participants: 446 · Started: 2026-10
Contact the study team
- Fate Clinical Trials · Phone: 858-875-1800
Official record on ClinicalTrials.gov — NCT07800871
Locations in the U.S.
| California | Providence Medical Foundation, Fullerton |
Conditions
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Myositis
- Rheumatoid Arthritis
- Lupus
- Scleroderma
- Dermatomyositis
- Polymyositis
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.