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Taking people in United StatesPhase 1/2

FT839 for Several Autoimmune Diseases, Including Lupus and Rheumatoid Arthritis

Tests the safety of FT839 in adults with autoimmune diseases.

Key facts

Who runs it
Fate Therapeutics
Where
Fullerton, United StatesSee the site
Trial code
Registry title
FT839 in Autoimmune Diseases
Status
Recruiting
Phase
Phase 1/2
People taking part
446 people, planned
Started
Oct 2026
Expected to end
Oct 2040
Type of study
Interventional, 8 groups
Treatments tested
  • FT839
Record updated
2 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with active, moderate to severe B-cell mediated autoimmune disease (AAV, IIM, RA, SLE or SSc) who have already tried at least two treatments that did not work.

Age
18 to 70 years
Sex
All sexes can join.
Disease stage
Active B-cell mediated autoimmune disease: AAV, IIM, RA, SLE or SSc, confirmed by standard criteria. Moderate to severe disease.
Earlier treatment
At least two earlier treatments that were ineffective. Cannot have had CAR T-cell therapy, an organ transplant, or any anti-CD19- or anti-CD20-directed therapy within 6 months before the trial treatment.

Main reasons for not taking part

  • More than 1 of the diseases under study, or an overlap syndrome
  • Pregnant or nursing women
  • Severe heart, lung, liver or kidney problems
  • Active or chronic infections, or active or recent cancer
  • Body weight under 45 kg (99 lb)

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in United States

  • Providence Medical FoundationFullerton, United StatesContact: Fate Clinical TrialsTaking people

About the trial

What the trial wants to find out

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.

The 8 groups in the trial

  • FT839 + Rituximab (Regimen A)Treatment being tested

    FT839, allogeneic T cells targeting CD19 and CD38

    Treatment: FT839

  • FT839 + Rituximab with stable background therapy (Regimen B)Treatment being tested

    FT839, allogeneic T cells targeting CD19 and CD38

    Treatment: FT839

  • FT839 monotherapy (Regimen C)Treatment being tested

    FT839, allogeneic T cells targeting CD19 and CD38

    Treatment: FT839

  • FT839 with stable background therapy (Regimen D)Treatment being tested

    FT839, allogeneic T cells targeting CD19 and CD38

    Treatment: FT839

  • Conditioning + FT839 + Rituximab (Regimen E)Treatment being tested

    FT839, allogeneic T cells targeting CD19 and CD38

    Treatment: FT839

  • Conditioning + FT839 + Rituximab with stable background therapy (Regimen F)Treatment being tested

    FT839, allogeneic T cells targeting CD19 and CD38

    Treatment: FT839

  • Conditioning + FT839 (Regimen G)Treatment being tested

    FT839, allogeneic T cells targeting CD19 and CD38

    Treatment: FT839

  • Conditioning + FT839 with stable background therapy (Regimen H)Treatment being tested

    FT839, allogeneic T cells targeting CD19 and CD38

    Treatment: FT839

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
FT839 for Several Autoimmune Diseases, Including Lupus and Rheumatoid ArthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07800871, who can take part
Record updated
2 September 2026