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Engineered immune cells take on Hard-to-Treat scleroderma in landmark trial

NCT ID NCT07335562

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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 3 times

Summary

This study tests whether a one-time infusion of specially engineered immune cells (CAR T cells) can improve lung function and skin hardening better than current treatments for people with active systemic sclerosis, a rare autoimmune disease. About 92 adults with lung involvement will be randomly assigned to receive either the CAR T therapy or standard care. The main goal is to see if the new treatment can increase lung capacity and reduce disease activity.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 92 people

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

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Nov 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

16 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 \- Participants must fulfill the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for Systemic Sclerosis (SSc), and additionally have the following:. i) Positive Antinuclear Antibodies (ANA) with nucleolar pattern and/or anti-Topoisomerase I (anti-Scl-70) antibodies. ii) Confirmation of Interstitial Lung Disease (ILD) on centrally read High-Resolution Computed Tomography (HRCT) with ≥ 10% total lung involvement, with at least one of the following attributed to active SSc:. A. Arthritis. B. Myositis. C. Carditis. D. Progressive skin disease. E. Elevated inflammatory markers. \- Participants must have a non-response or intolerance despite ≥ 6 months of treatment with at least one immunomodulatory drug. Non-response is defined as a patient, who in the opinion of the investigator, is not adequately controlled/treated and requires treatment escalation. Exclusion Criteria * Participants must not have a requirement for supplemental oxygen therapy and/or Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) ≤ 40% (Hemoglobin (Hgb) corrected) at screening. * Participants must not have moderate to severe Pulmonary Arterial Hypertension (PAH) requiring PAH-specific combination treatment * Participants must not have pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral corticosteroids, cigarette smoking (including e-cigarettes) within 3 months before screening or unwilling to avoid smoking throughout the study, and/or clinically significant abnormalities on HRCT not attributable to SSc assessed by the central reader at screening. * Participants must not have gastrointestinal (GI) dysmotility requiring Total Parenteral Nutrition (TPN). * Participants must not have current gangrene of a digit * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

systemic sclerosis

As listed by the trial registrant

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

Systemic sclerosis

How to take part

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

  1. The places running it

    56 sites in 10 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

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Emory University School of Medicine

    Atlanta, Georgia, 30322, United States

  • Local Institution - 0002

    Charleston, South Carolina, 29425, United States

  • Local Institution - 0004

    Milan, Milano, 20162, Italy

  • Local Institution - 0008

    Seattle, Washington, 98109, United States

  • Local Institution - 0009

    Málaga, 29011, Spain

  • Local Institution - 0012

    Bron, 69500, France

  • Local Institution - 0016

    Cologne, 50937, Germany

  • Local Institution - 0026

    Sapporo, Hokkaido, 0608648, Japan

  • Local Institution - 0028

    Erlangen, 91054, Germany

  • Local Institution - 0031

    Strasbourg, Alsace, 67098, France

  • Local Institution - 0032

    München, 80336, Germany

  • Local Institution - 0033

    Tübingen, 72076, Germany

  • Local Institution - 0034

    Ann Arbor, Michigan, 48109, United States

  • Local Institution - 0035

    Scottsdale, Arizona, 85259, United States

  • Local Institution - 0037

    Rochester, Minnesota, 55905, United States

  • Local Institution - 0038

    Würzburg, 97080, Germany

  • Local Institution - 0042

    Leipzig, 04103, Germany

  • Local Institution - 0046

    Berlin, 10117, Germany

  • Local Institution - 0047

    Basel, 4031, Switzerland

  • Local Institution - 0049

    Bordeaux, 33076, France

  • Local Institution - 0052

    Paris, 75679, France

  • Local Institution - 0057

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Local Institution - 0059

    London, NW3 2QG, United Kingdom

  • Local Institution - 0060

    Barcelona, 08907, Spain

  • Local Institution - 0061

    Toulouse, Haute-Garonne, 31059, France

  • Local Institution - 0063

    Leeds, North Yorkshire, LS7 4SA, United Kingdom

  • Local Institution - 0068

    Bern, 3010, Switzerland

  • Local Institution - 0069

    Miami, Florida, 33136, United States

  • Local Institution - 0074

    Dallas, Texas, 75390, United States

  • Local Institution - 0078

    Zurich, 8091, Switzerland

  • Local Institution - 0080

    Liège, 4000, Belgium

  • Local Institution - 0082

    Summit, New Jersey, 07901, United States

  • Local Institution - 0084

    Worcester, Massachusetts, 01655, United States

  • Local Institution - 0088

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Local Institution - 0091

    Sheffield, S10 2JF, United Kingdom

  • Local Institution - 0103

    Rome, Lazio, 00168, Italy

  • Local Institution - 0104

    Halifax, Nova Scotia, B3H2Y9, Canada

  • Local Institution - 0106

    Milan, 20132, Italy

  • Local Institution - 0108

    Pisa, Tuscany, 56126, Italy

  • Local Institution - 0117

    Bunkyo-ku, Tokyo, 1138603, Japan

  • Local Institution - 0118

    Okayama, 700-8558, Japan

  • Local Institution - 0123

    Fukuoka, 812-8582, Japan

  • Local Institution - 0129

    A Coruña, A Coruña [La Coruña], 15006, Spain

  • Local Institution - 0132

    Yokohama, Kanagawa, 236-0004, Japan

  • Local Institution - 0136

    Maebashi, 371-8511, Japan

  • Local Institution - 0137

    Suita, Osaka, 565-0871, Japan

  • Local Institution - 0138

    Barcelona, Catalunya [Cataluña], 08041, Spain

  • Local Institution - 0139

    Chicago, Illinois, 60611, United States

  • Local Institution - 0140

    London, London, City of, NW1 2PG, United Kingdom

  • Local Institution - 0141

    Rennes, 35033, France

  • Local Institution - 0142

    Philadelphia, Pennsylvania, 19104, United States

  • Local Institution - 0143

    Pittsburgh, Pennsylvania, 15224, United States

  • Local Institution - 0144

    Houston, Texas, 77030, United States

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

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