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Engineered immune cells take on lupus kidney disease

NCT ID NCT07570862

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 8 times

Summary

This phase 2 trial is testing a new treatment called FT819 for people with lupus nephritis, a serious kidney complication of lupus. FT819 is made from donor immune cells that are engineered to target and destroy faulty B cells. The study will enroll 53 participants and aims to see if a single infusion can improve kidney function and 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 CAR T-cell therapy made from donor cells)
What this could lead to
If it works, this could offer a new treatment option for people with hard-to-treat lupus kidney disease, potentially reducing the need for long-term medications.
What could go wrong
This is an early phase 2 trial with only 53 people, so results may not apply to everyone. CAR T-cell therapy can have serious side effects, and it's not yet known if the benefits will last.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 53 people

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

Started

Jul 2026

Expected to finish

Jan 2030

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.

INCLUSION CRITERIA: * Age ≥12 to ≤70 years * Diagnosis of SLE per EULAR/ACR 2019 classification criteria * Biopsy-proven proliferative Class III or IV LN, with or without concomitant Class V involvement, based on the 2003/2018 ISN/RPS classification * Positivity for at least one of the following autoantibodies at screening: 1. Antinuclear antibody (ANA) 2. Anti-double-stranded DNA (anti-dsDNA) or 3. Anti-Smith antibody * Active disease, defined as: a. Evidence of SLE activity, defined as either: i. SLEDAI-2K ≥6 or ii. At least 1 BILAG A or 2 BILAG B scores for SLE-related organ involvement; and b. Evidence of renal involvement, defined as UPCr ≥1 g/g; and c. Moderate-to-severe renal disease with investigator's impression that improvement is possible * Refractory to ≥2 systemic immunosuppressive therapies for the treatment of LN EXCLUSION CRITERIA: * Evidence of inadequate organ function during the screening period * Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention * History of or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with assessment of LN or confound evaluation of disease activity * Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention * Irreversible organ damage related to underlying disease (e.g., ESRD) where, in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant * History of malignancy in the prior 5 years * Known allergy to the following FT819 components: albumin (human) or DMSO * History of intolerance or contraindication to bendamustine * Body weight \<30 kg * Any medical condition, clinical laboratory abnormality, or nonmedical/social issue that, per investigator or medical monitor judgement, precludes safe participation in and completion of the trial or that could affect compliance with protocol conduct or interpretation of results

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Conditions

The condition(s) this trial relates to.

lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

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

Lupus nephritis Lupus nephritis - who class III Lupus nephritis - who class IV SLE - systemic lupus erythematosus Systemic lupus erythematosus

How to take part

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

  1. The places running it

    12 sites. 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

  • Cross Creek Medical Clinic

    RECRUITING

    Fayetteville, North Carolina, 28304, United States

  • GNP Research

    RECRUITING

    Cooper City, Florida, 33024, United States

  • Kaiser Permanente Fontana

    RECRUITING

    Fontana, California, 92335, United States

  • Miami Dermatology and Laser Research

    RECRUITING

    Miami, Florida, 33133, United States

  • Nicklaus Children's Hospital

    RECRUITING

    Miami, Florida, 33155, United States

  • Providence Medical Foundation

    RECRUITING

    Fullerton, California, 92835, United States

  • The University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of California Irvine

    RECRUITING

    Irvine, California, 92868, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 64110, United States

  • University of Florida Clinical Research Center

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68105, United States

  • Wallace Rheumatic Studies Center

    RECRUITING

    Beverly Hills, California, 90210, United States

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