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One-Time cell therapy could tame tough lupus

NCT ID NCT06581198

Disease control Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 2 times

Summary

This study tests a one-time treatment called rapcabtagene autoleucel, made from a patient's own immune cells, for people with active lupus or lupus kidney disease that hasn't improved with standard therapies. About 179 adults will receive the treatment after a short chemotherapy prep. The goal is to see if it can put lupus into remission or improve kidney function without needing lifelong medication, though ongoing monitoring for side effects is required.

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 179 people

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

Started

Sep 2024

Expected to finish

Feb 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

18 to 75 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: * Men and women with SLE, aged \>= 18 years and =\< 75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE at screening. * Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer of \>= 1:80 (on HEp-2 cells or an equivalent positive test), or anti-dsDNA (above the ULN); or anti-Sm (above the ULN) as determined by a central laboratory. * Active lupus nephritis without signs of significant chronicity or active systemic lupus erythematosus * SLEDAI-2K Criteria at screening: SLEDAI-2K score \>= 6 points (Gladman et al 2002, Touma et al 2011), excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome". * Inadequate response at screening to at least two therapies Key Exclusion Criteria: * Any acute, severe lupus related-flare at screening that needs immediate treatment other than pulse GCs and/or makes the immunosuppressive washout impossible and, thus, makes the participant ineligible for CD19 CAR-T therapy * Inadequate organ function during screening and prior to randomization * History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants prior to randomization * Human immunodeficiency virus (HIV) positivity at screening. * Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV) at screening. * Grade 2 or higher thromboembolic event in the past 4 weeks prior to screening. Other protocol-defined inclusion/exclusion criteria may 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

  • Ann and Robert H Lurie Childs Hosp

    Chicago, Illinois, 60611, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Duke Clinical Research Institute

    Durham, North Carolina, 27710, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • James Cancer Hospital

    Columbus, Ohio, 43210, United States

  • LDS Hospital

    Salt Lake City, Utah, 84143, United States

  • Loma Linda University

    San Bernardino, California, 92408, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1118AAT, Argentina

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5016KEH, Argentina

  • Novartis Investigative Site

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    Graz, 8036, Austria

  • Novartis Investigative Site

    Vienna, 1090, Austria

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Novartis Investigative Site

    Curitiba, Paraná, 80030-110, Brazil

  • Novartis Investigative Site

    Barretos, São Paulo, 14784-400, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01232-010, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01308-050, Brazil

  • Novartis Investigative Site

    São Paulo, 01509-010, Brazil

  • Novartis Investigative Site

    Olomouc, 779 00, Czechia

  • Novartis Investigative Site

    Prague, 128 00, Czechia

  • Novartis Investigative Site

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    Aarhus N, 8200, Denmark

  • Novartis Investigative Site

    Bordeaux, 33076, France

  • Novartis Investigative Site

    Clermont-Ferrand, 63003, France

  • Novartis Investigative Site

    Marseille, 13005, France

  • Novartis Investigative Site

    Montpellier, 34295, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Paris, 75013, France

  • Novartis Investigative Site

    Paris, 75014, France

  • Novartis Investigative Site

    Strasbourg, 67091, France

  • Novartis Investigative Site

    Toulouse, 31054, France

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511, France

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70376, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60528, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Lübeck, 23538, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Nuremberg, 90419, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Budapest, 1083, Hungary

  • Novartis Investigative Site

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Alessandria, AL, 15121, Italy

  • Novartis Investigative Site

    Ancona, AN, 60020, Italy

  • Novartis Investigative Site

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    Milan, MI, 20122, Italy

  • Novartis Investigative Site

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Pescara, PE, 65124, Italy

  • Novartis Investigative Site

    Pisa, PI, 56126, Italy

  • Novartis Investigative Site

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    Chiba, Chiba, 2608677, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608648, Japan

  • Novartis Investigative Site

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 2360004, Japan

  • Novartis Investigative Site

    Sendai, Miyagi, 9808574, Japan

  • Novartis Investigative Site

    Suita, Osaka, 5650871, Japan

  • Novartis Investigative Site

    Izumo, Shimane, 6938501, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138431, Japan

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 1138519, Japan

  • Novartis Investigative Site

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    Ishikawa, 9208641, Japan

  • Novartis Investigative Site

    Kyoto, 6068507, Japan

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64460, Mexico

  • Novartis Investigative Site

    Groningen, Provincie Groningen, 9713 GZ, Netherlands

  • Novartis Investigative Site

    Leiden, South Holland, 2333 ZA, Netherlands

  • Novartis Investigative Site

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    Oslo, 0372, Norway

  • Novartis Investigative Site

    Poznan, Greater Poland Voivodeship, 60-355, Poland

  • Novartis Investigative Site

    Lodz, 92-213, Poland

  • Novartis Investigative Site

    Bucharest, 022328, Romania

  • Novartis Investigative Site

    Riyadh, 11211, Saudi Arabia

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Seoul, Seoul, 06351, South Korea

  • Novartis Investigative Site

    Seoul, 04763, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Stockholm, 17176, Sweden

  • Novartis Investigative Site

    Lausanne, 1011, Switzerland

  • Novartis Investigative Site

    Taichung, 407219, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Sheffield, South Yorkshire, S10 2JF, United Kingdom

  • Novartis Investigative Site

    London, W12 0HS, United Kingdom

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Sutter Health Network

    San Pablo, California, 94806, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UCSF

    San Francisco, California, 94115, United States

  • Univ Of TX MD Anderson CC

    Houston, Texas, 77030, United States

  • University Of Alabama

    Birmingham, Alabama, 35294, United States

  • University Of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kentucky

    Lexington, Kentucky, 40536-0284, United States

  • WA Uni School Of Med

    St Louis, Missouri, 63110, United States

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