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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06581198
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Novartis Pharmaceuticals
Principal Investigator Affiliation	Novartis Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Austria, Czechia, Denmark, France, Germany, Italy, Japan, Netherlands, Norway, Romania, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lupus Erythematosus, Systemic, Lupus Nephritis

Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Biological: - rapcabtagene autoleucel Regimen 1

single infusion of rapcabtagene autoleucel

Biological: - rapcabtagene autoleucel Regimen 2

single infusion of rapcabtagene autoleucel

Other: - Standard of Care

The treatment regimen must be in line with KDIGO guidelines for treatment of class III/IV LN.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCSF, San Francisco 5391959, California 5332921

Status

Recruiting

Address

UCSF

San Francisco 5391959, California 5332921, 94115

Site Contact

Zilan Zheng

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