A Study of Rapcabtagene Autoleucel in Systemic Lupus Erythematosus (SLE) Patients With Active, Refractory Lupus Nephritis (LN)

Key Inclusion Criteria:

• Men and women with SLE, aged >= 18 years and =< 65 years at screening, fulfillingthe 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 atscreening: antinuclear antibodies (ANA) at a titer of >= 1:80 (on HEp-2 cells or anequivalent 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 treatmentother 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 significantrisk 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.

• Vaccination (including with live attenuated vaccines) not completed at least 6 weeksprior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply.