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Lupus Erythematosus, SystemicPhase 2NCT06581198

A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)

A Phase 2 study testing rapcabtagene autoleucel in people with Lupus Erythematosus, Systemic and Lupus Nephritis, run by Novartis Pharmaceuticals at 107 sites in 26 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
rapcabtagene autoleucel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
107 sitesin 26 countries
Study dates
4 Sep 2024to 6 Feb 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

107 sites in 26 countries.

107 sites in 26 countries

United States17 sites

  • University Of Alabama

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Ann and Robert H Lurie Childs Hosp

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • James Cancer Hospital

    Columbus, Ohio, 43210

  • Duke Clinical Research Institute

    Durham, North Carolina, 27710

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Univ Of TX MD Anderson CC

    Houston, Texas, 77030

  • University Of Iowa

    Iowa City, Iowa, 52242

  • University of Kentucky

    Lexington, Kentucky, 40536-0284

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Loma Linda University

    San Bernardino, California, 92408

  • UCSF

    San Francisco, California, 94115

  • Sutter Health Network

    San Pablo, California, 94806

  • WA Uni School Of Med

    St Louis, Missouri, 63110

Other trials in United States

Japan12 sites

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138431

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 1138519

  • Novartis Investigative Site

    Chiba, Chiba, 2608677

  • Novartis Investigative Site

    Fukuoka, 8128582

  • Novartis Investigative Site

    Ishikawa, 9208641

  • Novartis Investigative Site

    Izumo, Shimane, 6938501

  • Novartis Investigative Site

    Kobe, Hyōgo, 6500047

  • Novartis Investigative Site

    Kyoto, 6068507

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608648

  • Novartis Investigative Site

    Sendai, Miyagi, 9808574

  • Novartis Investigative Site

    Suita, Osaka, 5650871

  • Novartis Investigative Site

    Yokohama, Kanagawa, 2360004

Other trials in Japan

France10 sites

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

  • Novartis Investigative Site

    Marseille, 13005

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Nantes, 44093

  • Novartis Investigative Site

    Paris, 75013

  • Novartis Investigative Site

    Paris, 75014

  • Novartis Investigative Site

    Strasbourg, 67091

  • Novartis Investigative Site

    Toulouse, 31054

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany10 sites

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60528

  • Novartis Investigative Site

    Jena, Thuringia, 07740

  • Novartis Investigative Site

    Leipzig, Saxony, 04103

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Nuremberg, 90419

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70376

  • Novartis Investigative Site

    Ulm, 89081

Other trials in Germany

Italy9 sites

  • Novartis Investigative Site

    Alessandria, AL, 15121

  • Novartis Investigative Site

    Ancona, AN, 60020

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Milan, MI, 20122

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Pescara, PE, 65124

  • Novartis Investigative Site

    Pisa, PI, 56126

  • Novartis Investigative Site

    Rozzano, MI, 20089

Other trials in Italy

Spain9 sites

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Córdoba, 14004

  • Novartis Investigative Site

    Madrid, 28009

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

  • Novartis Investigative Site

    Salamanca, 37007

  • Novartis Investigative Site

    Santander, Cantabria, 39008

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706

  • Novartis Investigative Site

    Valencia, 46026

Other trials in Spain

Brazil6 sites

  • Novartis Investigative Site

    Barretos, São Paulo, 14784-400

  • Novartis Investigative Site

    Curitiba, Paraná, 80030-110

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 41253-190

  • Novartis Investigative Site

    São Paulo, São Paulo, 01232-010

  • Novartis Investigative Site

    São Paulo, São Paulo, 01308-050

  • Novartis Investigative Site

    São Paulo, 01509-010

Other trials in Brazil

Argentina3 sites

  • Novartis Investigative Site

    CABA, Buenos Aires, C1118AAT

  • Novartis Investigative Site

    CABA, C1181ACH

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5016KEH

Other trials in Argentina

Czechia3 sites

  • Novartis Investigative Site

    Olomouc, 779 00

  • Novartis Investigative Site

    Prague, 128 00

  • Novartis Investigative Site

    Prague, 128 08

Other trials in Czechia

Israel3 sites

  • Novartis Investigative Site

    Haifa, 3109601

  • Novartis Investigative Site

    Ramat Gan, 5265601

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Netherlands3 sites

  • Novartis Investigative Site

    Groningen, Provincie Groningen, 9713 GZ

  • Novartis Investigative Site

    Leiden, South Holland, 2333 ZA

  • Novartis Investigative Site

    Utrecht, 3584 CX

Other trials in Netherlands

South Korea3 sites

  • Novartis Investigative Site

    Seoul, Seoul, 06351

  • Novartis Investigative Site

    Seoul, 04763

  • Novartis Investigative Site

    Seoul, 06591

Other trials in South Korea

Austria2 sites

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Vienna, 1090

Other trials in Austria

Hungary2 sites

  • Novartis Investigative Site

    Budapest, 1083

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032

Other trials in Hungary

Poland2 sites

  • Novartis Investigative Site

    Lodz, 92-213

  • Novartis Investigative Site

    Poznan, Greater Poland Voivodeship, 60-355

Other trials in Poland

Taiwan2 sites

  • Novartis Investigative Site

    Taichung, 407219

  • Novartis Investigative Site

    Taipei, 10002

Other trials in Taiwan

United Kingdom2 sites

  • Novartis Investigative Site

    London, W12 0HS

  • Novartis Investigative Site

    Sheffield, South Yorkshire, S10 2JF

Other trials in United Kingdom

Australia1 site

  • Novartis Investigative Site

    Clayton, Victoria, 3168

Other trials in Australia

Denmark1 site

  • Novartis Investigative Site

    Aarhus N, 8200

Other trials in Denmark

Mexico1 site

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Norway1 site

  • Novartis Investigative Site

    Oslo, 0372

Other trials in Norway

Romania1 site

  • Novartis Investigative Site

    Bucharest, 022328

Other trials in Romania

Saudi Arabia1 site

  • Novartis Investigative Site

    Riyadh, 11211

Other trials in Saudi Arabia

Singapore1 site

  • Novartis Investigative Site

    Singapore, 119074

Other trials in Singapore

Sweden1 site

  • Novartis Investigative Site

    Stockholm, 17176

Other trials in Sweden

Switzerland1 site

  • Novartis Investigative Site

    Lausanne, 1011

Other trials in Switzerland

About this study

Official title: A Phase 2, Open-label, Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel in Patients With Active, Refractory Systemic Lupus Erythematosus (SLE) or Active, Refractory Lupus Nephritis (LN).

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN).

Being tested
rapcabtagene autoleucel
Keywords
Chimeric Antigen Receptor-T (CAR-T), rapcabtagene autoleucel, Lupus Nephritis (LN), Systemic Lupus Erythematosus (SLE)
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rapcabtagene autoleucelBiological

    single infusion of rapcabtagene autoleucel

Study groups in NCT06581198
Study groupRoleWhat they receive
rapcabtagene autoleucelExperimentalrapcabtagene autoleucel
Receives: Biological: rapcabtagene autoleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the efficacy of rapcabtagene autoleucel

    Defined as:

    Meeting the criteria of the Definition Of Remission In Systemic Lupus Erythematosus (DORIS)

    or

    Achieving complete renal response (CRR)

    Measured: Week 24, Week 52

Secondary outcomes (7)

  1. Percentage of participants achieving complete renal response (CRR)

    CRR is a composite endpoint

    Measured: Week 52

  2. Number of weeks where Lupus Low Disease Activity Score (LLDAS) was achieved

    Lupus Low Disease Activity State (LLDAS)

    Measured: Week 12 to Week 52

  3. PPercentage of participants without flaring (i.e., 1 new BILAG2004 A or 2 new BILAG2004 B flares)

    British Isles Lupus Activity Group (BILAG2004) records disease activity occurring over the past 4 weeks.

    Measured: Week 12 to Week 52

  4. Annualized cumulative corticosteroids dose

    The total dose of corticosteroids used up to Week 52 per patient.

    Measured: Week 52

  5. Percentage of participants who are negative for serological status

    The percentage of participants with negative serological status

    Measured: Week 52

  6. FACIT-Fatigue score change from baseline

    Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item patient- reported outcomes measure

    Measured: Baseline to Week 52

  7. Maintained DORIS

    Definition Of Remission In Systemic Lupus Erythematosus (DORIS)

    Measured: Week 52 to Week 76

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2024
  2. Study start4 Sep 2024
  3. Primary completion14 Feb 2028 (estimated)
  4. Study completion6 Feb 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
179 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06581198
Sponsor's protocol ID
CYTB323J12201
Other IDs
2023-510150-17-00, 2023
Status last verified
Aug 2026
First submitted
23 Aug 2024
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rapcabtagene autoleucel in people with Lupus Erythematosus, Systemic and Lupus Nephritis, run by Novartis Pharmaceuticals at 107 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Japan, France, Germany, Italy and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the efficacy of rapcabtagene autoleucel (time frame: Week 24, Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06581198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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