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

Launched by NOVARTIS PHARMACEUTICALS · Aug 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called rapcabtagene autoleucel for patients with systemic lupus erythematosus (SLE) who also have a serious kidney condition known as lupus nephritis (LN) that hasn't responded to standard treatments. The goal is to see how effective and safe this new treatment is compared to the usual care for these patients. The study is currently recruiting participants aged 18 to 65 who have been diagnosed with SLE and have certain autoantibodies in their blood, indicating active disease. Participants must also have active lupus nephritis and have not responded well to at least two previous treatments.

If eligible, participants can expect to receive the new treatment in a single dose after a preparation process, and they will be monitored for any side effects and improvements in their condition. It's important to note that those with certain health issues or recent infections may not qualify for the trial. Overall, this study aims to explore a potentially new option for patients facing challenges in managing their lupus and related kidney problems.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Men and women with SLE, aged \>= 18 years and =\< 65 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
• • 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 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.
• • Evidence of active or latent tuberculosis.
• • Grade 2 or higher thromboembolic event in the past 4 weeks prior to screening.
• • Other protocol-defined inclusion/exclusion criteria may apply.