Study Description
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) versus Standard of Care (SOC) in patients with systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN). This is a Phase 2, adaptive, five-year, randomized, assessor-blinded, active controlled study:
* Part A: Participants suffering from systemic lupus erythematosus (SLE) with active, refractory LN will be randomized to Regimen 1, Regimen 2, or SOC.
* Part B: Participants suffering from SLE with active, refractory LN will be randomized to the selected regimen from Part A or SOC.
The study will consist of two periods:
* A screening period lasting up to 6 weeks, and
* A randomized treatment period and primary follow-up period lasting up to 5 years.
Participants in the SoC arm whose signs and symptoms are not fully controlled may receive rapcabtagene autoleucel treatment once the participant is confirmed to be eligible.
Interventions
rapcabtagene autoleucel Regimen 1
rapcabtagene autoleucel Regimen 2
Standard of Care
Eligibility Criteria
Key Inclusion Criteria:
* Men and women with SLE, aged \>= 18 years and =\< 65 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
* 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 LN treatment regimens
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.
* Evidence of active or latent tuberculosis.
* 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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Olomouc,779 00,Czechia
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Praha 2,128 50,Czechia
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Nantes,44093,France
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Paris,75013,France
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Vandoeuvre Les Nancy,54511,France
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Bordeaux Cedex,33076,France
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Leipzig,Sachsen,04103,Germany
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Ulm,89081,Germany
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Essen,45147,Germany
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Mainz,55131,Germany
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Jena,07740,Germany
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Ancona,AN,60126,Italy
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Rozzano,MI,20089,Italy
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Genova,GE,16132,Italy
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Milano,MI,20122,Italy
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Milano,MI,20132,Italy
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Pisa,PI,56124,Italy
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Pavia,PV,27100,Italy
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Chiba,2608677,Japan
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Kobe,Hyogo,650-0047,Japan
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Yokohama-city,Kanagawa,236-0004,Japan
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Kyoto,606 8507,Japan
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Fukuoka city,Fukuoka,812-8582,Japan
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Suita,Osaka,565 0871,Japan
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Kanazawa,Ishikawa,920 8641,Japan
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Izumo-city,Shimane,693 8501,Japan
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Sapporo city,Hokkaido,060 8648,Japan
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Sendai city,Miyagi,980 8574,Japan
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Bunkyo-ku,Tokyo,113-8519,Japan
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Seoul,06591,Korea, Republic of
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Groningen,9713 gz,Netherlands
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Utrecht,3584,Netherlands
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Bucharest,022328,Romania
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Salamanca,Castilla Y Leon,37007,Spain
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Santiago De Compostela,Galicia,15706,Spain
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Pamplona,Navarra,31008,Spain
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Barcelona,Catalunya,08035,Spain
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Valencia,46026,Spain
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Madrid,28041,Spain
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Cordoba,Andalucia,14004,Spain
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Lausanne,1011,Switzerland
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Taichung,407219,Taiwan
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London,W12 0hs,United Kingdom
Boston Medical Center
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Boston,Massachusetts,02118,United States
Hanni Menn-Josephy
Tufts Medical Center
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Boston,Massachusetts,02111,United States
Andreas Klein
LDS Hospital
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Salt Lake City,Utah,84143,United States
Catherine Jennifer Bakewell
University of Texas MD Anderson Cancer Center
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Houston,Texas,77030,United States
Samer Srour
University Of Iowa
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Iowa City,Iowa,52242,United States
Hanna Zembrzuska
University of Kentucky
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Lexington,Kentucky,40536-0284,United States
Paramarajan Piranavan
UCSF
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San Francisco,California,94115,United States
Emily Von Scheven
Northwestern University
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Chicago,Illinois,60611,United States
George Georges
Matthew Selle
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
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