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

JRCT ID: jRCT2013240039

Registered date:15/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN)
• Date of first enrollment: 18/10/2024
• Target sample size: 15
• Countries of recruitment: Singapore,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Percentage of participants achieving clinical response at Week 52.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Yamauchi Kyosuke
• Secondary ID(s): NCT06581198