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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

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 to week 76 for reporting.

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 more

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.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,889 Previous Clinical Trials

4,201,860 Total Patients Enrolled

8 Trials studying Lupus Nephritis

1,200 Patients Enrolled for Lupus Nephritis

~96 spots leftby Jun 2029

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