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This Phase 2 study evaluates the efficacy and safety of rapcabtagene autoleucel in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN). The therapy is administered once following lymphodepletion. Eligible men and women are aged 18 to 75 years, fulfill the 2019 EULAR/ACR classification criteria for SLE at screening, and must be positive for at least one of the protocol-specified antibodies.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.