Study Description
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).
Interventions
rapcabtagene autoleucel
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.
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Clayton,Victoria,3168,Australia
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Vienna,1090,Austria
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São Paulo,01509-010,Brazil
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São Paulo,São Paulo,01232-010,Brazil
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Salvador,Estado de Bahia,41253-190,Brazil
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Prague,128 00,Czechia
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Olomouc,779 00,Czechia
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Aarhus N,8200,Denmark
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Vandœuvre-lès-Nancy,54511,France
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Marseille,13005,France
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Paris,75014,France
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Nantes,44093,France
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Paris,75013,France
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Toulouse,31054,France
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Bordeaux,33076,France
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Essen,45147,Germany
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Jena,Thuringia,07740,Germany
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Nuremberg,90419,Germany
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Leipzig,Saxony,04103,Germany
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Mainz,55131,Germany
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Ulm,89081,Germany
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Budapest,H-1083,Hungary
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Pavia,PV,27100,Italy
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Milan,MI,20132,Italy
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Milan,MI,20122,Italy
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Genova,GE,16132,Italy
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Ancona,AN,60126,Italy
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Rozzano,MI,20089,Italy
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Pisa,PI,56126,Italy
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Sapporo,Hokkaido,060 8648,Japan
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Fukuoka,Fukuoka,812-8582,Japan
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Kobe,Hyōgo,650-0047,Japan
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Kanazawa,Ishikawa-ken,920 8641,Japan
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Sendai,Miyagi,980 8574,Japan
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Yokohama,Kanagawa,236-0004,Japan
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Suita,Osaka,565 0871,Japan
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Izumo,Shimane,693 8501,Japan
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Bunkyo Ku,Tokyo,113-8431,Japan
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Chiba,2608677,Japan
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Bunkyo-ku,Tokyo,113-8519,Japan
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Kyoto,606 8507,Japan
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Groningen,9713 gz,Netherlands
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Leiden,South Holland,2333 za,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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Singapore,119074,Singapore
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Seoul,06591,South Korea
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Córdoba,14004,Spain
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Salamanca,Castille and León,37007,Spain
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Barcelona,Catalonia,08035,Spain
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Pamplona,Navarre,31008,Spain
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Santiago Compostela,A Coruna,15706,Spain
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Madrid,28009,Spain
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Madrid,28041,Spain
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Santander,Cantabria,39008,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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Taipei,10002,Taiwan
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Taichung,407219,Taiwan
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London,W12 0hs,United Kingdom
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Sheffield,South Yorkshire,S10 2jf,United Kingdom
University of Texas MD Anderson Cancer Center
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Houston,Texas,77030,United States
Christle Joy Roan
Samer Srour
Northwestern University
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Chicago,Illinois,60611,United States
Tyler Sorensen
Sonali Chaudhury
Matthew Selle
George Georges
LDS Hospital
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Salt Lake City,Utah,84143,United States
Catherine Jennifer Bakewell
UCSF
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San Francisco,California,94115,United States
Emily Von Scheven
University Of Iowa
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Iowa City,Iowa,52242,United States
Hanna Zembrzuska
Boston Medical Center
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Boston,Massachusetts,02118,United States
Hanni Menn-Josephy
University of Kentucky
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Lexington,Kentucky,40536-0284,United States
Natalie Jo Hawes
Paramarajan Piranavan
Oregon Health Sciences University
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Portland,Oregon,97239,United States
Atul Deodhar
Sutter Health Network
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San Pablo,California,94806,United States
Neftali Nevarez
Yomi Kapasi
Tufts Medical Center
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Boston,Massachusetts,02111,United States
Andreas Klein
Worldwide Contacts
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