Overview

This is a Phase 2, adaptive, five-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 5 years.

Participants in the SoC arm whose signs and symptoms are not fully controlled may receive rapcabtagene autoleucel treatment once the participant is confirmed to be eligible.

Principal investigator

Hanna Zembrzuska
Internal Medicine

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.
Show more

Participate in this trial

Are you interested in enrolling in this study? Learn more here.

I'm Interested In Participating

For Referring Providers

Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.

Contact the study coordinator

Darby Donovan
Enroll your patient