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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06581198
Registration number
NCT06581198
Ethics application status
Date submitted
23/08/2024
Date registered
3/09/2024
Date last updated
29/08/2025
Titles & IDs
Public title
A Study of Rapcabtagene Autoleucel in Systemic Lupus Erythematosus (SLE) Patients With Active, Refractory Lupus Nephritis (LN)
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Scientific title
A Phase 2, Adaptive, Randomized, Open-label, Assessor-blinded Active-controlled Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Standard of Care in Patients Suffering From Systemic Lupus Erythematosus (SLE) With Active, Refractory Lupus Nephritis (LN).
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Secondary ID [1]
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2023-510150-17-00
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Secondary ID [2]
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CYTB323J12201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lupus Erythematosus, Systemic
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Lupus Nephritis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - rapcabtagene autoleucel Regimen 1
Treatment: Other - rapcabtagene autoleucel Regimen 2
Other interventions - Standard of Care
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.
Treatment: Other: rapcabtagene autoleucel Regimen 1
single infusion of rapcabtagene autoleucel
Treatment: Other: rapcabtagene autoleucel Regimen 2
single infusion of rapcabtagene autoleucel
Other interventions: Standard of Care
The treatment regimen must be in line with KDIGO guidelines for treatment of class III/IV LN.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part A and Part B: Percentage of participants achieving clinical response at Week 52.
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Assessment method [1]
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Clinical response is defined as meeting the criteria of the Definition Of Remission In Systemic Lupus Erythematosus (DORIS) AND maintaining treatment with low dose glucocorticoids (GCs) from Week 24 onward as defined by: * Clinical Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K of 0 at Week 52 AND * Achieving a Physician Global Assessment (PhGA) score of \<0.5 at Week 52 AND * GC treatment with low prednisone dose/day or equivalent from Week 24 onward AND * Stable immunomodulatory/immunosuppressive treatment.
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Part A and Part B: Percentage of participants achieving complete renal response (CRR) at Week 52
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Assessment method [1]
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CRR is a composite endpoint defined as: estimated glomerular filtration rate (eGFR) = 90 ml/min/1.73 m2 (eGFR within normal range) or no less than 85% of baseline AND 24-hour UPCR \< 0.5
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Part A and Part B: Number of weeks where Lupus Low Disease Activity Score (LLDAS) was achieved from Week 12 until Week 52
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Assessment method [2]
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Lupus Low Disease Activity State (LLDAS) has been described and validated for SLE participants and is defined by: * SLEDAI-2K score of = 4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) * No new lupus disease activity compared with the previous assessment * Physician global assessment (PhGA, scale 0-3) = 1 * Current GC (predniso(lo)ne or equivalent) dose = 7.5 mg/day * Well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs * No discontinuation of investigational product * No use of restricted medications beyond the protocol-allowed threshold before assessment.
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Timepoint [2]
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Week 12 to Week 52
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Secondary outcome [3]
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Part A and Part B: Percentage of participants without flaring (i.e., 1 new BILAG2004 A or 2 new BILAG2004 B flares) from Week 12 through Week 52
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Assessment method [3]
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British Isles Lupus Activity Group (BILAG2004) records disease activity occurring over the past 4 weeks. The BILAG2004 index covers 97 items, and the assessment is based on the principle of the doctor's intent to treat, which requires an assessment as 0 = not present, 1 = improving, 2 = same, 3 = worse, or 4 = new over the last month.
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Timepoint [3]
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Week 12 to Week 52
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Secondary outcome [4]
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Part A and Part B: Annualized cumulative corticosteroids dose until Week 52
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Assessment method [4]
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The total dose of corticosteroids used up to Week 52 per patient.
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Timepoint [4]
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Week 52
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Secondary outcome [5]
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Part A and Part B: Percentage of participants who are negative (i.e., titer within normal limits) for antinuclear antibodies (ANA), anti-dsDNA, and anti-Sm at Week 52
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Assessment method [5]
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The percentage of participants who are negative for antinuclear antibodies anti-dsDNA \& anti-Sm will be analyzed like the Clinical Response.
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Week 52
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Secondary outcome [6]
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Part A and Part B: FACIT-Fatigue score change from baseline at Week 52
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Assessment method [6]
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Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item patient-reported outcomes measure) that assesses self-reported fatigue and its impact upon daily activities and function over the past week. For FACIT, the score ranges from 0 to 52, with lower values indicating less fatigue.
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Timepoint [6]
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Baseline to Week 52
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Secondary outcome [7]
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Part A and Part B: Percentage of participants who were in Sustained Remission at Week 52 to Week 76
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Assessment method [7]
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Sustained remission is defined as follows: Clinical SLEDAI-2K=0 from Week 52 to Week 76, Physician Global Assessment \< 0.5 (PhGA, scale 0-3) from Week 52 to Week 76, The participant must be on stable treatment from Week 52 to Week 76.
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Timepoint [7]
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Week 52 to Week 76
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Eligibility
Key inclusion criteria
Key
* 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
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Minimum age
18
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/09/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
7/06/2033
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Actual
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Sample size
Target
144
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment outside Australia
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California
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Funding & Sponsors
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Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) versus Standard of Care (SOC) in patients with systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN).
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Trial website
https://clinicaltrials.gov/study/NCT06581198
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for public queries
Name
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Novartis Pharmaceuticals
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Phone
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1-888-669-6682
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06581198
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