NCT07800871RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 446 (estimated)
- First submitted
- 24 Aug 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- Fate Therapeutics
- Diseases
- Lupus (SLE), Systemic sclerosis (scleroderma), Rheumatoid arthritis, ANCA-associated vasculitis
- NCT number
- NCT07800871
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 446
- From 1 Oct 2026 to the primary completion date, 31 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior CAR T-cell therapy or organ transplantation
- 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
Other illness
- Diagnosis of more than 1 disease under study (AAV, IIM, RA, SSc, or SLE) or overlap syndrome
- Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.
- Active or chronic infections
- Active or recent malignancies
- Known allergies to study treatments
Other
- Women must not be pregnant or nursing
- Body weight \<45 kg
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Providence Medical Foundation Coordinator of this site? Confirm its status | Fullerton | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.