FT839 therapy for autoimmune diseases
Official title: An Open-Label, Multicenter, Phase 1/2 Dose-Escalation and Expansion Trial Evaluating the Safety and Efficacy of FT839 in Participants With Autoimmune Diseases
Run by Fate Therapeutics · NCT07800871 · Data updated 2026-11-12
This trial tests FT839, given alone or with rituximab, to see if it is safe and can help people with certain autoimmune diseases who have not responded to other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 446 (estimated) |
| Sponsor | Fate Therapeutics Industry-sponsored |
| Drugs / interventions | CAR T, rituximab |
| Locations | 1 site (Fullerton, California) |
| Status | Recruiting |
| Started | October 2026 |
| Main results expected | October 2028 |
| Study ends | October 2040 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT07800871 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–70 with active, B-cell–mediated autoimmune diseases (AAV, IIM, RA, SLE, or SSc) who have not responded adequately to at least two prior therapies.
✕Probably not a fit
Patients with non–B-cell–mediated disease, significant organ dysfunction, recent active malignancy, or prior CAR T-cell therapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter Phase 1/2 open-label study to evaluate the safety, pharmacokinetics, and early clinical activity of FT839 in adults with active B-cell–mediated autoimmune diseases (AAV, IIM, RA, SLE, SSc). Participants may receive FT839 alone or with rituximab and may have conditioning therapy and/or background medications. The Phase 1 part uses dose escalation and expansion to identify the recommended Phase 2 dose based on safety and tolerability, with monitoring for dose-limiting toxicities through day 29 and long-term follow-up for safety and survival up to 15 years. The Phase 2 portion will further assess efficacy within disease-specific cohorts after safety signals are established.
Why it matters
Potential benefit: If successful, participants could experience improved disease control and symptom relief from FT839 treatment.
How similar studies have gone: Previous studies of related cellular therapies in autoimmune diseases have shown varying safety signals and early activity; this approach is exploratory in this disease range.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Providence Medical Foundation
Fullerton, California, United States Recruiting
Study contacts
- Study coordinator: Fate Clinical Trials
- Email: clinicaltrials@fatetherapeutics.com
- Phone: 858-875-1800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.