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A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
Sponsor: Novartis Pharmaceuticals
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).
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).
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
179
Start Date
2024-09-04
Completion Date
2032-02-06
Last Updated
2026-02-20
Healthy Volunteers
No
Interventions
rapcabtagene autoleucel
single infusion of rapcabtagene autoleucel
Locations (93)
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
Oregon Health Sciences University
Portland, Oregon, 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
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Vienna, Austria
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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
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Prague, Czechia
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Aarhus N, Denmark
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Bordeaux, France
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Marseille, France
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Nantes, France
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Paris, France
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Paris, France
Novartis Investigative Site
Strasbourg, France
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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
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Essen, Germany
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Mainz, Germany
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Nuremberg, Germany
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Ulm, Germany
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Debrecen, Hajdu Bihar Megye, Hungary
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Budapest, Hungary
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Ramat Gan, Israel
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Alessandria, AL, Italy
Novartis Investigative Site
Ancona, AN, Italy
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Milan, MI, Italy
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Milan, MI, Italy
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Rozzano, MI, Italy
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Pescara, PE, Italy
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Pisa, PI, Italy
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Pavia, PV, Italy
Novartis Investigative Site
Sapporo, Hokkaido, Japan
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Kobe, Hyōgo, Japan
Novartis Investigative Site
Kanazawa, Ishikawa-ken, Japan
Novartis Investigative Site
Yokohama, Kanagawa-ku, 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
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Fukuoka, Japan
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Kyoto, Japan
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Leiden, South Holland, Netherlands
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Groningen, Netherlands
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Utrecht, Netherlands
Novartis Investigative Site
Oslo, Norway
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Bucharest, Romania
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Riyadh, Saudi Arabia
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Singapore, Singapore
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Seoul, South Korea
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
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Santander, Cantabria, Spain
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Pamplona, Navarre, Spain
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Barcelona, Spain
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Córdoba, Spain
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Madrid, Spain
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Madrid, Spain
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Salamanca, Spain
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Valencia, Spain
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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