RecruitingPhase 2NCT06581198

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

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).

Sponsor

Novartis Pharmaceuticals

Enrollment

179 participants

Start Date

Sep 4, 2024

Study Type

INTERVENTIONAL

Conditions

Lupus Erythematosus, Systemic Lupus Nephritis

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called rapcabtagene autoleucel for people with lupus erythematosus, systemic and lupus nephritis. The study is currently recruiting participants at 101 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALrapcabtagene autoleucel

single infusion of rapcabtagene autoleucel

Locations(101)

University Of Alabama

Birmingham, Alabama, United States

Loma Linda University

San Bernardino, California, United States

UCSF

San Francisco, California, United States

UCSF

San Francisco, California, United States

Sutter Health Network

San Pablo, California, United States

Ann and Robert H Lurie Childs Hosp

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

University Of Iowa

Iowa City, Iowa, United States

University of Kentucky

Lexington, Kentucky, United States

Tufts Medical Center

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

WA Uni School Of Med

St Louis, Missouri, United States

Duke Clinical Research Institute

Durham, North Carolina, United States

Oregon Health Sciences University

Portland, Oregon, United States

Houston Methodist Hospital

Houston, Texas, United States

Univ Of TX MD Anderson CC

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

LDS Hospital

Salt Lake City, Utah, United States

LDS Hospital

Salt Lake City, Utah, United States

Novartis Investigative Site

Clayton, Victoria, Australia

Novartis Investigative Site

Graz, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Novartis Investigative Site

Barretos, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, Brazil

Novartis Investigative Site

Olomouc, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Aarhus N, Denmark

Novartis Investigative Site

Bordeaux, France

Novartis Investigative Site

Clermont-Ferrand, France

Novartis Investigative Site

Marseille, France

Novartis Investigative Site

Nantes, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Strasbourg, France

Novartis Investigative Site

Toulouse, France

Novartis Investigative Site

Vandœuvre-lès-Nancy, France

Novartis Investigative Site

Stuttgart, Baden-Wurttemberg, Germany

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Leipzig, Saxony, Germany

Novartis Investigative Site

Jena, Thuringia, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Lübeck, Germany

Novartis Investigative Site

Mainz, Germany

Novartis Investigative Site

Nuremberg, Germany

Novartis Investigative Site

Ulm, Germany

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Haifa, Israel

Novartis Investigative Site

Ramat Gan, Israel

Novartis Investigative Site

Tel Aviv, Israel

Novartis Investigative Site

Alessandria, AL, Italy

Novartis Investigative Site

Ancona, AN, Italy

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Rozzano, MI, Italy

Novartis Investigative Site

Pescara, PE, Italy

Novartis Investigative Site

Pisa, PI, Italy

Novartis Investigative Site

Pavia, PV, Italy

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Kobe, Hyōgo, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Sendai, Miyagi, Japan

Novartis Investigative Site

Suita, Osaka, Japan

Novartis Investigative Site

Izumo, Shimane, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Novartis Investigative Site

Chiba, Japan

Novartis Investigative Site

Fukuoka, Japan

Novartis Investigative Site

Ishikawa, Japan

Novartis Investigative Site

Kyoto, Japan

Novartis Investigative Site

Leiden, South Holland, Netherlands

Novartis Investigative Site

Groningen, Netherlands

Novartis Investigative Site

Utrecht, Netherlands

Novartis Investigative Site

Oslo, Norway

Novartis Investigative Site

Bucharest, Romania

Novartis Investigative Site

Riyadh, Saudi Arabia

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Novartis Investigative Site

Santander, Cantabria, Spain

Novartis Investigative Site

Pamplona, Navarre, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Córdoba, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Salamanca, Spain

Novartis Investigative Site

Valencia, Spain

Novartis Investigative Site

Stockholm, Sweden

Novartis Investigative Site

Lausanne, Switzerland

Novartis Investigative Site

Taichung, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Sheffield, South Yorkshire, United Kingdom

Novartis Investigative Site

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06581198

Related Trials

PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis

NCT0761121415 locations

A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease

NCT0692554214 locations

Trial of Belimumab in Early Lupus

NCT035438391 location

A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE

NCT0689793018 locations

US Zamto-cel Autoimmune Diseases

NCT067088451 location