Last Update: Jun 03, 2026 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). ClinicalTrials.gov Identifier: [NCT06581198](https://clinicaltrials.gov/ct2/show/NCT06581198) Novartis Reference Number:CYTB323J12201 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## 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). Condition Lupus Erythematosus, Systemic, Lupus Nephritis Phase Phase2 Overall Status Recruiting Number of Participants179 Start Date Sep 04, 2024 Completion Date Feb 06, 2032 Gender All Age(s) 18 Years - 75 Years (Adult, Older Adult) ## Interventions Biological ### rapcabtagene autoleucel single infusion of 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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