FT839 for Several Autoimmune Diseases, Including Lupus and Rheumatoid Arthritis
Tests the safety of FT839 in adults with autoimmune diseases.
Plain-language title generated from the registry record
Registry title: FT839 in Autoimmune Diseases
Key facts
- Where
- Fullerton, United StatesSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07800871, who can take part
Where in United States
- Providence Medical FoundationFullerton, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fate Therapeutics
- Trial code
- NCT07800871
- Record updated
- 2 September 2026
- Original description
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.Read full original descriptionShow less
An Open-Label, Multicenter, Phase 1/2 Dose-Escalation and Expansion Trial Evaluating the Safety and Efficacy of FT839 in Participants With Autoimmune Diseases
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.
Inclusion: 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: 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; 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; Women must not be pregnant or nursing; Body weight <45 kg.