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Bored Studies
RecruitingPhase 1/Phase 2

FT839 in Autoimmune Diseases

Fate Therapeutics · NCT07800871

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
446
US sites recruiting
1
Study start
October 2026
Record last updated
September 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: FT839

Conditions: ANCA-Associated Vasculitis (AAV); Idiopathic Inflammatory Myositis (IIM); Rheumatoid Arthritis (RA); Systemic Lupus Erythematosus (SLE); Systemic Sclerosis (SSc)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • Fate Clinical Trials · 858-875-1800 · clinicaltrials@fatetherapeutics.com
  • Natalie Shiff, MD
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FT839 in Autoimmune Diseases (NCT07800871) | Bored Studies