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

179 patients around the world

Available in United States, Brazil

Novartis Pharmaceuticals

179Patients around the world

This study is for people with

Lupus

Systemic lupus erythematosus

Lupus nephritis

To 75 Years

All Gender

: 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.

: 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.

SponsorNovartis Pharmaceuticals

Study typeInterventional

Conditions

Systemic lupus erythematosusLupus nephritis

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06581198