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

NCT06581198 · Novartis
In plain English

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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).
About this study
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
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.
Study design
Enrollment target: 179 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-04
Estimated completion: 2032-02-06
Last updated: 2026-02-20
Interventions
Biological: rapcabtagene autoleucel
Primary outcomes
  • Evaluate the efficacy of rapcabtagene autoleucel (Week 24, Week 52)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · +41613241111
InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals
All locations (93)
University Of AlabamaRecruiting
Birmingham, Alabama, United States
Loma Linda UniversityRecruiting
San Bernardino, California, United States
UCSFRecruiting
San Francisco, California, United States
UCSFRecruiting
San Francisco, California, United States
Sutter Health NetworkRecruiting
San Pablo, California, United States
Ann and Robert H Lurie Childs HospRecruiting
Chicago, Illinois, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
University Of IowaRecruiting
Iowa City, Iowa, United States
University of KentuckyRecruiting
Lexington, Kentucky, United States
Tufts Medical CenterRecruiting
Boston, Massachusetts, United States
Boston Medical CenterRecruiting
Boston, Massachusetts, United States
WA Uni School Of MedRecruiting
St Louis, Missouri, United States
Oregon Health Sciences UniversityRecruiting
Portland, Oregon, United States
Univ Of TX MD Anderson CCRecruiting
Houston, Texas, United States
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
LDS HospitalRecruiting
Salt Lake City, Utah, United States
LDS HospitalRecruiting
Salt Lake City, Utah, United States
Novartis Investigative SiteRecruiting
Clayton, Victoria, Australia
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Graz, Austria
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Vienna, Austria
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Salvador, Estado de Bahia, Brazil
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Barretos, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, Brazil
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Olomouc, Czechia
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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
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Strasbourg, France
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Toulouse, France
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Vandœuvre-lès-Nancy, France
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Stuttgart, Baden-Wurttemberg, Germany
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Frankfurt am Main, Hesse, Germany
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Cologne, North Rhine-Westphalia, Germany
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Leipzig, Saxony, Germany
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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
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Ancona, AN, Italy
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Genova, GE, Italy
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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
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Sapporo, Hokkaido, Japan
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Kobe, Hyōgo, Japan
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Kanazawa, Ishikawa-ken, Japan
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Yokohama, Kanagawa-ku, Japan
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Sendai, Miyagi, Japan
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Suita, Osaka, Japan
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Izumo, Shimane, Japan
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Bunkyo Ku, Tokyo, Japan
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Bunkyo-ku, Tokyo, Japan
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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
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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
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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
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Lausanne, Switzerland
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Taichung, Taiwan
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Taipei, Taiwan
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Sheffield, South Yorkshire, United Kingdom
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London, United Kingdom