A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)

Korábbi kezelés

• 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
• Grade 2 or higher thromboembolic event in the past 4 weeks prior to screening.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Más betegség

• Human immunodeficiency virus (HIV) positivity at screening.
• Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV) at screening.

• 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