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A Study of Rapcabtagene Autoleucel for Lupus

This study is testing a treatment called rapcabtagene autoleucel for people with active, difficult-to-treat systemic lupus erythematosus (SLE) or lupus nephritis (LN). Rapcabtagene autoleucel works by using a CAR-T mechanism, which involves modifying your own immune cells to fight the disease. The main goal is to see how well rapcabtagene autoleucel works and if it's safe. Researchers will check its effectiveness at 24 and 52 weeks. You might be able to join if you are between 18 and 75 years old, have SLE, and test positive for certain autoantibodies like antinuclear antibodies (ANA). The current status of this study is unclear, and it plans to enroll 179 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 179 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate the efficacy of rapcabtagene autoleucel at Week 24 and Week 52.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06581198

A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)

Active, Not Recruiting
PHASE2Ages 18–75InterventionalTreatment
Novartis Pharmaceuticals
~179 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:rapcabtagene autoleucel

At a glance

Recruiting sites
0 of 107 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the efficacy of rapcabtagene autoleucel
Measured over Week 24, Week 52

Conditions

Lupus Erythematosus, Systemic
Lupus Nephritis

Explore related trials

Lupus GlomerulonephritisSystemic Lupus ErythematosusAnti-ds DNA AntibodyAntinuclear Antibodyanti-Sm

NCT06581198

Where you'd take part

This study runs at 107 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ann and Robert H Lurie Childs Hosp

    Chicago, Illinoisno site contact published

  • Boston Medical Center

    Boston, Massachusettsno site contact published

  • Duke Clinical Research Institute

    Durham, North Carolinano site contact published

  • Houston Methodist Hospital

    Houston, Texasno site contact published

  • James Cancer Hospital

    Columbus, Ohiono site contact published

  • LDS Hospital

    Salt Lake City, Utahno site contact published

  • Loma Linda University

    San Bernardino, Californiano site contact published

  • Northwestern University

    Chicago, Illinoisno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Evaluate the efficacy of rapcabtagene autoleucelWeek 24, Week 52

    Defined as: Meeting the criteria of the Definition Of Remission In Systemic Lupus Erythematosus (DORIS) or Achieving complete renal response (CRR)