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Engineered immune cells aim to tame lupus without daily pills

NCT ID NCT07015983

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Updated 2 times

Summary

This phase 2 trial tests a one-time treatment called CC-97540, made from a patient's own immune cells engineered to target and calm the overactive immune system in lupus. The study enrolls 89 adults with active lupus (including kidney inflammation) who have not responded well to steroids and at least two other immunosuppressants. The main goal is to see if participants can achieve drug-free remission, meaning no lupus symptoms and no need for lupus medications.

What this could mean

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

Active substance
CC-97540 (a type of CAR T-cell therapy that targets CD19 on immune cells)
What this could lead to
If successful, this could offer a new treatment option that allows people with lupus to stop taking daily medications and achieve long-term remission.
What could go wrong
This is an early phase 2 trial with only 89 participants, so results may not apply to everyone. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and infections.

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 89 people

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

Started

Jul 2025

Expected to finish

Jun 2032

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 meet EULAR/ACR 2019 criteria for SLE. * Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months. * Participants must have active disease when signing ICF. Exclusion Criteria: * Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE. * Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years, except for some non-invasive malignancies. * IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant. * Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, stem cell transplant or organ transplant. * Participants must not have received live vaccines within 6 weeks before LDC (lymphodepleting chemotherapy) administration. * Participant must not have inadequate organ function. * Other protocol-defined inclusion/exclusion criteria apply.

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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 erythematosus, systemic Lupus nephritis

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Milano, 20162, Italy

  • Atlantic Health System Overlook Medical Center

    Summit, New Jersey, 07901, United States

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120, United States

  • Baylor Scott and White Research Institute

    Dallas, Texas, 75246, United States

  • CHU Montpellier Lapeyronie Hospital

    Montpellier, Hérault, 34295, France

  • Carolinas HealthCare System SouthPark

    Charlotte, North Carolina, 28211, United States

  • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

    Rennes, 35033, France

  • Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria

    Lisbon, Lisbon District, 1649-035, Portugal

  • Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

    Berlin, 10117, Germany

  • Chiba University Hospital

    Chiba, 260-8677, Japan

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Columbia University Pediatrics

    New York, New York, 10032, United States

  • Derriford Hospital, University Hospitals Plymouth NHS Trust

    Crownhill, Plymouth, PL6 8DH, United Kingdom

  • Emory University School of Medicine

    Atlanta, Georgia, 30322, United States

  • Florida Medical Clinic Orlando Health

    Zephyrhills, Florida, 33542, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Rome, Lazio, 00168, Italy

  • H.R.U Málaga - Hospital General

    Málaga, 29011, Spain

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 0608648, Japan

  • Hospital Aleman

    Buenos Aires, Buenos Aires F.D., C1118AAT, Argentina

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120, Spain

  • Hospital Italiano de Buenos Aires

    ABB, Buenos Aires F.D., C1199ABB, Argentina

  • Hospital La Princesa

    Madrid, 28006, Spain

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Keio university hospital

    Shinjuku-ku, Tokyo, 1608582, Japan

  • King's College Hospital

    London, London, City of, SE5 9RL, United Kingdom

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Local Institution - 0011

    Rochester, Minnesota, 55905, United States

  • Local Institution - 0021

    São Paulo, São Paulo, 01409-001, Brazil

  • Local Institution - 0022

    São Paulo, 05652-900, Brazil

  • Local Institution - 0038

    Los Angeles, California, 90027, United States

  • Local Institution - 0047

    Copenhagen, Capital Region, 2100, Denmark

  • Local Institution - 0051

    Los Angeles, California, 90095, United States

  • Local Institution - 0058

    São Paulo, São Paulo, 01509-010, Brazil

  • Local Institution - 0070

    Pisa, Tuscany, 56126, Italy

  • Local Institution - 0073

    Orlando, Florida, 32803, United States

  • Local Institution - 0077

    Córdoba, X5016, Argentina

  • Local Institution - 0079

    Atlanta, Georgia, 30322, United States

  • Local Institution - 0081

    Toulouse, Haute-Garonne, 31059, France

  • Local Institution - 0082

    New York, New York, 10016, United States

  • Local Institution - 0083

    Philadelphia, Pennsylvania, 19104, United States

  • Local Institution - 0086

    Baton Rouge, Louisiana, 70836, United States

  • Local Institution - 0088

    Donostia / San Sebastian, Gipuzkoa, 20014, Spain

  • Local Institution - 0090

    Metropolitan Borough of Wirral, Merseyside, L63 4JY, United Kingdom

  • Local Institution - 0091

    Liverpool, L9 7AL, United Kingdom

  • Local Institution - 0093

    Newport Beach, California, 92663, United States

  • Local Institution - 0094

    Boston, Massachusetts, 02114, United States

  • Local Institution - 0096

    Ann Arbor, Michigan, 48109, United States

  • Local Institution - 0098

    Dallas, Texas, 75390-9068, United States

  • Local Institution - 0099

    Toronto, Ontario, M5T 2S8, Canada

  • Local Institution - 0101

    Manhasset, New York, 11030, United States

  • Local Institution - 0104

    San Antonio, Texas, 78229, United States

  • Local Institution - 0106

    Phoenix, Arizona, 85054, United States

  • Local Institution - 0107

    Buenos Aires, B1629ODT, Argentina

  • Local Institution - 0108

    Indianapolis, Indiana, 46250, United States

  • Local Institution - 0109

    Strasbourg, 67098, France

  • Local Institution - 0110

    Shreveport, Louisiana, 71101, United States

  • Local Institution - 0111

    Stony Brook, New York, 11794, United States

  • Local Institution - 0132

    Odense, Region Syddanmark, 5000, Denmark

  • Local Institution - 0134

    Paris, Île-de-France Region, 75015, France

  • Local Institution - 0135

    Winston-Salem, North Carolina, 27106, United States

  • Lucile Packard Children's Hospital

    Palo Alto, California, 94304, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224, United States

  • Medizinische Universität Wien

    Vienna, State of Vienna, 1090, Austria

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach

    Gliwice, Silesian Voivodeship, 44-101, Poland

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • Odense Universitetshospital

    Odense, Region Syddanmark, 5000, Denmark

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586, Japan

  • Ospedale Pediatrico Bambino Gesù IRCCS

    Rome, Roma, 00165, Italy

  • Pitie Salpetriere University Hospital

    Paris, Île-de-France Region, 75013, France

  • Rheumazentrum Ruhrgebiet

    Herne, 44649, Germany

  • Sheba Medical Center

    Ramat Gan, Central District, 5262100, Israel

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Szpital Specjalistyczny nr 1 w Bytomiu

    Bytom, Silesian Voivodeship, 41-902, Poland

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • USF Health

    Tampa, Florida, 33612, United States

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Uniklinikum Salzburg

    Salzburg, 5020, Austria

  • Universitaetsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitaetsklinikum Magdeburg

    Magdeburg, Saxony-Anhalt, 39120, Germany

  • University College London Hospital

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

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Miami Hospital and Clinics, Sylvester Cancer Center

    Miami, Florida, 33136, United States

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103, Germany

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004, Japan

More trials for these conditions

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