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Could a One-Time cell infusion tame lupus and other autoimmune diseases?

NCT ID NCT06308978

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study is testing a new cell therapy called FT819 for people with severe autoimmune diseases like lupus, vasculitis, and scleroderma. The treatment involves giving specially engineered immune cells along with chemotherapy drugs. The main goal is to see if it's safe and to find the right dose, with a secondary look at whether it can control the disease.

What this could mean

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

Active substance
FT819 (a type of immune cell therapy made from stem cells, given by IV)
What this could lead to
If it works, this could point toward a new treatment option for people with severe autoimmune diseases like lupus that haven't responded to other therapies.
What could go wrong
This is a very early (Phase 1) trial, so the main goal is safety, not effectiveness. It's small and may not lead to a proven treatment. There are also risks from the chemotherapy drugs given alongside FT819.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 244 people

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

Started

Mar 2024

Expected to finish

Sep 2042

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

12 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.

Key Inclusion Criteria: * Age: 12 to 70 years old. * Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria. * Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective. * Health Status: Adequate organ function to tolerate treatment. * Consent: Able to provide informed consent or assent/obtain parental consent and comply with study procedures. Key Exclusion Criteria: * Pregnancy/Breastfeeding: Women must not be pregnant or nursing. * Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment. * Active Infections: No recent or ongoing serious infections. * Recent Cancer or Prior Cell Therapy: No active/recent malignancies, prior CAR T-cell therapy, or organ transplant. * Allergies: No known allergies to study treatments. * Weight Restriction: Must weigh at least 50 kg (110 lbs).

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy anti-neutrophil cytoplasmic antibody-associated vasculitis autoimmune disease granulomatosis with polyangiitis lupus nephritis myositis disease systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

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

Antineutrophilic cytoplasmic antibody (ANCA)- associated vasculitis (AAV) Idiopathic inflammatory myositis (IIM) Lupus nephritis 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

    21 sites in 4 countries. 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

  • Cambridge University Hospitals NHS Foundation Trust

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Children's Hospital Los Angeles Division Of Rheumatology

    RECRUITING

    Los Angeles, California, 90027, United States

  • Duke University Health System

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Hôpital La Pitié Salpêtrière

    RECRUITING

    Paris, 75013, France

  • Jefferson Einstein Hospital Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19141, United States

  • Manchester University NHS Foundation Trust

    RECRUITING

    Manchester, Greater Manchester, M139WL, United Kingdom

  • MetroHealth

    RECRUITING

    Cleveland, Ohio, 44109, United States

  • Montefiore Medical Center

    RECRUITING

    New York, New York, 10467, United States

  • Nicklaus Children's Hospital

    RECRUITING

    Miami, Florida, 33155, United States

  • Providence Medical Foundation

    RECRUITING

    Fullerton, California, 92835, United States

  • Regional One Health

    RECRUITING

    Memphis, Tennessee, 38103, United States

  • University College of London Hospitals NHS Trust (UCLH)

    RECRUITING

    London, NW1 2PQ, United Kingdom

  • University of California Irvine

    RECRUITING

    Irvine, California, 92868, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94110, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Minnesota Medical School

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Oklahoma

    RECRUITING

    Oklahoma City, Oklahoma, 73019, United States

  • Uppsala University

    RECRUITING

    Uppsala, Uppland, 752 37, Sweden

  • Wallace Rheumatic Center

    RECRUITING

    Beverly Hills, California, 90210, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.