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Donor immune cells aim to tame autoimmune attacks

NCT ID NCT07115745

Disease control Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This early-stage study tests a new treatment made from healthy donor immune cells (CAR T cells) for people with severe autoimmune diseases like lupus that haven't responded to standard therapies. The goal is to see if these cells can safely target and calm the overactive immune system. About 125 participants will receive the treatment and be monitored for side effects and effectiveness.

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 125 people

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

Started

Sep 2025

Expected to finish

Aug 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

18 years and older

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 \- Systemic lupus erythematosus (SLE) population:. i) Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR). ii) Participant must be positive for at least one of the following antibodies at screening: anti-nuclear antibody, anti-dsDNA, anti-histone, anti-chromatin or anti-Sm antibody. iii) Inadequate response or intolerance to steroids and immunosuppressive therapies. iv) Participants must have active disease at screening. \- Inflammatory myopathy (IIM) population:. i) Participants meeting the 2017 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria. ii) Participants must meet criteria for with severe, refractory IIM. iii) Participants who had inadequate response to steroids and prior immunosuppressive therapies. iv) Evidence of active disease. \- Systemic sclerosis (SSc) population:. i) Participant must fulfill the 2013 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis. ii) Inadequate disease response or intolerance to prior therapies. iii) Participants diagnosed with progressive systemic sclerosis including skin disease and/or interstitial lung disease. \- Rheumatoid arthritis (RA) population:. i) Participants with difficult to treat RA. ii) Participants with a diagnosis of RA meeting 2010 ACR/EULAR criteria. iii) Rheumatoid arthritis disease activity at screening and baseline visit. iv) Inadequate disease response or intolerance to standard of care therapy. Exclusion Criteria \- All participants:. i) Any other systemic autoimmune disease. ii) Pregnant or nursing women. iii) Active hepatitis B, C or HIV. iv) Prior history of malignancies. v) Uncontrolled or active infection. vi) History of certain cardiovascular conditions within 6 months prior to screening. vii) Previous CAR-T cell therapy. viii) Significant lung impairment. ix) Inadequate organ function. x) Active, clinically significant, central nervous system (CNS) disorders. * SLE population:. i) Participants who have SLE because of drugs or have other autoimmune diseases along with SLE. * IIM population:. i) Participants who have other forms of myopathies other than IIM. ii) Severe muscle damage. * SSc population:. i) People who have high blood pressure in the arteries of the lungs caused by SSc, which needs regular treatment to keep it under control. ii) Rapidly deteriorating SSc, or history of severe kidney disease. * RA population:. i) People who have additional autoimmune diseases along with RA. * Other protocol-defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

autoimmune disease connective tissue disorder dermatomyositis diffuse scleroderma inclusion body myositis lupus nephritis musculoskeletal system disorder myositis disease polymyositis rheumatoid arthritis Sclerosis skin disorder systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

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

Refractory autoimmune diseases

How to take part

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

  1. The places running it

    23 sites in 9 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

  • ARENSIA Exploratory Medicine

    RECRUITING

    Cluj-Napoca, Cluj, 400015, Romania

  • Brigham And Womens Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CHU Strasbourg-Hautepierre

    RECRUITING

    Strasbourg, Alsace, 67098, France

  • Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

    RECRUITING

    Berlin, 10117, Germany

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705-2771, United States

  • Fundeni Clinical Institute

    RECRUITING

    Bucharest, 022328, Romania

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hopital Claude Huriez - CHU de Lille

    RECRUITING

    Lille, Nord, 59037, France

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Catalunya [Cataluña], 08041, Spain

  • Local Institution - 0004

    NOT_YET_RECRUITING

    Prague, Praha 5, 150 06, Czechia

  • Local Institution - 0007

    WITHDRAWN

    Camperdown, New South Wales, 2050, Australia

  • Local Institution - 0008

    WITHDRAWN

    Brisbane, Queensland, 4029, Australia

  • Local Institution - 0013

    WITHDRAWN

    Clayton, Victoria, 3168, Australia

  • Local Institution - 0017

    WITHDRAWN

    Lodz, Łódź Voivodeship, 93-513, Poland

  • Local Institution - 0031

    WITHDRAWN

    Hamburg, 20246, Germany

  • Local Institution - 0038

    NOT_YET_RECRUITING

    São Paulo, 01508-010, Brazil

  • Local Institution - 0039

    NOT_YET_RECRUITING

    Porto Alegre, 0, Brazil

  • Local Institution - 0040

    NOT_YET_RECRUITING

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w Gliwicach

    RECRUITING

    Gliwice, Silesian Voivodeship, 44-100, Poland

  • Revmatologicky ustav

    RECRUITING

    Prague, 12850, Czechia

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, Central District, 5262100, Israel

  • Szpital Specjalistyczny nr 1 w Bytomiu

    RECRUITING

    Bytom, Silesian Voivodeship, 41-902, Poland

  • Universitaetsklinikum Duesseldorf

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    RECRUITING

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

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