Clinical Trial Finder

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.

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

Other protocol-defined inclusion/exclusion criteria may apply.

This is a Phase 2, adaptive, two-year, randomized, assessor-blinded, active controlled study:

• - Part A: Participants suffering from systemic lupus erythematosus (SLE) with active, refractory LN will be randomized to Regimen 1, Regimen 2, or SOC.

• - Part B: Participants suffering from SLE with active, refractory LN will be randomized to the selected regimen from Part A or SOC.

The study will consist of two periods:

• - A screening period lasting up to 6 weeks, and.

• - A randomized treatment period and primary follow-up period lasting up to 104 weeks.

After end of study (EOS), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period lasting up to 15 years after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.

Arms

Experimental: Regimen 1

rapcabtagene autoleucel Regimen 1

Experimental: Regimen 2

rapcabtagene autoleucel Regimen 2

Active Comparator: Standard of Care

The treatment regimen must be in line with Kidney Disease Improving Global Outcomes (KDIGO) guidelines for treatment of class III/IV LN.

Interventions

Biological: - rapcabtagene autoleucel Regimen 1

single infusion of rapcabtagene autoleucel

Biological: - rapcabtagene autoleucel Regimen 2

single infusion of rapcabtagene autoleucel

Other: - Standard of Care

The treatment regimen must be in line with KDIGO guidelines for treatment of class III/IV LN.