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Can a single cell therapy calm multiple autoimmune diseases?

NCT ID NCT07800871

Disease control Sponsor: Fate Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests an investigational cell therapy called FT839 in people with active autoimmune diseases, including ANCA-associated vasculitis, inflammatory myositis, rheumatoid arthritis, lupus, and systemic sclerosis. Participants receive FT839 as two intravenous infusions, sometimes combined with rituximab or other background treatments. The study first checks safety and tolerability, then measures whether FT839 reduces disease activity using condition-specific scores. It is open to adults aged 18 to 70 with moderate to severe disease who have not responded to at least two prior treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FT839, an investigational cell therapy given as two intravenous infusions, tested alone or with rituximab and other background treatments
What this could lead to
If it works, FT839 could offer a new way to calm the immune system and reduce disease activity in several autoimmune conditions, potentially helping people who have not responded to other treatments.
What could go wrong
This is an early-phase trial, so the safety and effectiveness of FT839 are not yet proven. It may not work for all the diseases studied, and there are risks of side effects from the cell therapy and the conditioning or background treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 446 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2040

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy anti-neutrophil cytoplasmic antibody-associated vasculitis dermatomyositis granulomatosis with polyangiitis myositis disease polymyositis rheumatoid arthritis systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ANCA associated vasculitis (AAV) Idiopathic inflammatory myositis (IIM) Rheumatoid arthritis (RA) Systemic lupus erythematosus (SLE) Systemic sclerosis (SSC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Providence Medical Foundation

    RECRUITING

    Fullerton, California, 92835, United States

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