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CAR T-cell Therapy
Rapcabtagene Autoleucel for Lupus Nephritis
Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Active lupus nephritis without signs of significant chronicity
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
Must not have
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
Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV) at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52 to week 76
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to compare the effectiveness and safety of rapcabtagene autoleucel with the standard treatment in patients with lupus and kidney inflammation that has not responded to standard treatment."
Who is the study for?
This trial is for people with active, hard-to-treat lupus nephritis—a kidney condition caused by systemic lupus erythematosus. Participants should have tried other treatments without success. Specific criteria for joining or reasons to be excluded aren't provided here.
What is being tested?
The study tests two different dosing regimens of a new therapy called rapcabtagene autoleucel against the standard treatment for lupus nephritis. It aims to see if this new approach is more effective and safe compared to what's currently used.
What are the potential side effects?
Possible side effects are not detailed here, but generally, therapies like rapcabtagene autoleucel could cause immune reactions, infusion-related symptoms, or impact blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have active lupus affecting my kidneys without long-term damage.
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I am between 18 and 65 years old and have been diagnosed with lupus according to the 2019 EULAR/ACR criteria.
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I have tried at least two treatments for my condition without success.
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I have tested positive for specific autoantibodies related to my condition.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a severe lupus flare that needs immediate treatment beyond pulse GCs.
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I have hepatitis B or C.
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I have signs of active or latent tuberculosis.
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My organs are not functioning properly.
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I have no significant heart problems that would put me at risk.
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I am HIV positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52 to week 76
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52 to week 76
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A and Part B: Percentage of participants achieving clinical response at Week 52.
Secondary study objectives
Part A and Part B: Annualized cumulative corticosteroids dose until Week 52
Part A and Part B: FACIT-Fatigue score change from baseline at Week 52
Part A and Part B: Number of weeks where Lupus Low Disease Activity Score (LLDAS) was achieved from Week 12 until Week 52
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Regimen 2Experimental Treatment1 Intervention
rapcabtagene autoleucel Regimen 2
Group II: Regimen 1Experimental Treatment1 Intervention
rapcabtagene autoleucel Regimen 1
Group III: Standard of CareActive Control1 Intervention
The treatment regimen must be in line with Kidney Disease Improving Global Outcomes (KDIGO) guidelines for treatment of class III/IV LN.
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,919 Previous Clinical Trials
4,254,363 Total Patients Enrolled