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Evaluating a new CAR-T therapy for lupus nephritis patients

A Phase 2, Open-label, Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel in Patients With Active, Refractory Systemic Lupus Erythematosus (SLE) or Active, Refractory Lupus Nephritis (LN).

Phase 2 Interventional Novartis · NCT06581198

This study is testing a new CAR-T therapy to see if it can help people with lupus nephritis who haven't responded well to other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment179 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsCAR-T
Locations93 sites (Birmingham, Alabama and 92 other locations)
Trial IDNCT06581198 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of rapcabtagene autoleucel, a chimeric antigen receptor-T (CAR-T) therapy, in patients with systemic lupus erythematosus (SLE) who have active, refractory lupus nephritis (LN). Participants will be randomized to receive either the new CAR-T treatment or standard of care, with a follow-up period lasting up to five years. The study includes a screening phase of up to six weeks, followed by a randomized treatment phase. The goal is to determine if the CAR-T therapy can provide better outcomes compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with active lupus nephritis and inadequate response to previous treatments.

Not a fit: Patients with acute, severe lupus-related flares requiring immediate treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could offer a new treatment option for patients with difficult-to-treat lupus nephritis.

How similar studies have performed: While CAR-T therapies have shown promise in other autoimmune conditions, this specific application in lupus nephritis is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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

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.
* Grade 2 or higher thromboembolic event in the past 4 weeks prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Birmingham, Alabama and 92 other locations

+43 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lupus Erythematosus, SystemicLupus NephritisChimeric Antigen Receptor-Trapcabtagene autoleucelSystemic Lupus Erythematosus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.