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NCT06581198PHASE2Recruiting

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

Novartis Pharmaceuticals

Start Date

9/4/2024

Completion Date

2/6/2032

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).

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

BIOLOGICAL

rapcabtagene autoleucel

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Conditions

Lupus Erythematosus, SystemicLupus Nephritis

Locations

University Of Alabama

Birmingham, Alabama 35294

United States

Loma Linda University

San Bernardino, California 92408

United States

UCSF

San Francisco, California 94115

United States

UCSF

San Francisco, California 94115

United States

Sutter Health Network

San Pablo, California 94806

United States

Ann and Robert H Lurie Childs Hosp

Chicago, Illinois 60611

United States

Northwestern University

Chicago, Illinois 60611

United States

University Of Iowa

Iowa City, Iowa 52242

United States

University of Kentucky

Lexington, Kentucky 40536-0284

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

WA Uni School Of Med

St Louis, Missouri 63110

United States

Duke Clinical Research Institute

Durham, North Carolina 27710

United States

Oregon Health Sciences University

Portland, Oregon 97239

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

Univ Of TX MD Anderson CC

Houston, Texas 77030

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

LDS Hospital

Salt Lake City, Utah 84143

United States

LDS Hospital

Salt Lake City, Utah 84143

United States

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

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

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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

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Nantes, 44093

France

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Paris, 75013

France

Novartis Investigative Site

Paris, 75014

France

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Strasbourg, 67091

France

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Toulouse, 31054

France

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Vandœuvre-lès-Nancy, 54511

France

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Stuttgart, Baden-Wurttemberg 70376

Germany

Novartis Investigative Site

Frankfurt am Main, Hesse 60528

Germany

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Cologne, North Rhine-Westphalia 50937

Germany

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Leipzig, Saxony 04103

Germany

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Jena, Thuringia 07740

Germany

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Essen, 45147

Germany

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Lübeck, 23538

Germany

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Mainz, 55131

Germany

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Nuremberg, 90419

Germany

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Ulm, 89081

Germany

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Debrecen, Hajdu Bihar Megye 4032

Hungary

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Budapest, H-1083

Hungary

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Haifa, 3109601

Israel

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Ramat Gan, 5265601

Israel

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Tel Aviv, 6423906

Israel

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Alessandria, AL 15121

Italy

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Ancona, AN 60126

Italy

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Genova, GE 16132

Italy

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Milan, MI 20122

Italy

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Milan, MI 20132

Italy

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Rozzano, MI 20089

Italy

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Pescara, PE 65124

Italy

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Pisa, PI 56126

Italy

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Pavia, PV 27100

Italy

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Sapporo, Hokkaido 060-8648

Japan

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Kobe, Hyōgo 6500047

Japan

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Yokohama, Kanagawa 236-0004

Japan

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Sendai, Miyagi 9808574

Japan

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Suita, Osaka 565-0871

Japan

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Izumo, Shimane 6938501

Japan

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Bunkyo Ku, Tokyo 1138431

Japan

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Bunkyo-ku, Tokyo 1138519

Japan

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Chiba, 2608677

Japan

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Fukuoka, 8128582

Japan

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Ishikawa, 9208641

Japan

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Kyoto, 6068507

Japan

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Leiden, South Holland 2333 ZA

Netherlands

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Groningen, 9713 GZ

Netherlands

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Utrecht, 3584 CX

Netherlands

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Oslo, 0372

Norway

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Bucharest, 022328

Romania

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Riyadh, 11211

Saudi Arabia

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Singapore, 119074

Singapore

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Seoul, 04763

South Korea

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Seoul, 06351

South Korea

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Seoul, 06591

South Korea

Novartis Investigative Site

Santiago Compostela, A Coruna 15706

Spain

Novartis Investigative Site

Santander, Cantabria 39008

Spain

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Pamplona, Navarre 31008

Spain

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Barcelona, 08035

Spain

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Córdoba, 14004

Spain

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Madrid, 28009

Spain

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Madrid, 28041

Spain

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Salamanca, 37007

Spain

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Valencia, 46026

Spain

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Stockholm, 17176

Sweden

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Lausanne, 1011

Switzerland

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Taichung, 407219

Taiwan

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Taipei, 10002

Taiwan

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Sheffield, South Yorkshire S10 2JF

United Kingdom

Novartis Investigative Site

London, W12 0HS

United Kingdom