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CAR T-cell Therapy

CAR T-Cell Therapy for Lupus Nephritis

Phase 1 & 2
Recruiting
Research Sponsored by Kyverna Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of SLE according to 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria
Biopsy-proven proliferative LN Class III or IV according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial tests a new therapy for lupus nephritis, using modified cells to target and destroy the disease in refractory cases.

Who is the study for?
This trial is for adults over 18 with a clinical diagnosis of Systemic Lupus Erythematosus (SLE) who meet specific criteria, including positive tests for certain autoantibodies and biopsy-proven proliferative lupus nephritis. Participants must be up to date on vaccinations, including COVID-19. Those with severe neurological disorders, active hepatitis B or C, HIV, primary immunodeficiency, significant heart disease or previous malignancies (with some exceptions), or prior cellular/gene therapy are excluded.Check my eligibility
What is being tested?
The study is testing KYV-101 anti-CD19 CAR-T cell therapy in subjects with refractory lupus nephritis that hasn't responded to other treatments. It involves modifying the patient's T-cells to target CD19 protein on B cells implicated in SLE. The treatment follows a standard lymphodepletion regimen which prepares the body for receiving these modified T-cells.See study design
What are the potential side effects?
Potential side effects may include immune system reactions like cytokine release syndrome (flu-like symptoms), neurologic toxicities such as confusion or seizures, infusion-related reactions, increased risk of infections due to immune suppression from lymphodepletion and CAR-T therapy itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with lupus according to the 2019 EULAR/ACR criteria.
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My kidney biopsy shows I have a severe type of inflammation.
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I have tested positive for specific autoimmune markers.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of dose limiting toxicities at each dose level (Phase 1)
Incidence adverse events (AEs) and laboratory abnormalities (Phase 1 and Phase 2)
To Evaluate efficacy (Phase 2)
Secondary outcome measures
To assess PRO after infusion of KYV-101 (Phase 1 and Phase 2)
To characterize the pharmacodynamics (PD) (Phase 1 and Phase 2)
To characterize the pharmacokinetics (PK) (Phase 1 and Phase 2)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 2)Experimental Treatment2 Interventions
Recommended Phase 2 Dose
Group II: KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 1)Experimental Treatment2 Interventions
Dosing with KYV-101 CAR T cells

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Lupus Nephritis include immunosuppressive therapies such as corticosteroids, cyclophosphamide, and mycophenolate mofetil, which work by reducing the activity of the immune system to prevent further kidney damage. Novel treatments like Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy specifically target B cells by engineering T cells to recognize and destroy CD19-expressing B cells, which are responsible for producing autoantibodies that attack the kidneys. This targeted approach is significant for Lupus Nephritis patients as it aims to reduce the autoimmune response more precisely, potentially leading to better outcomes with fewer side effects compared to broad immunosuppression.
[Depletion of plasma cells - a novel strategy in the therapy of systemic lupus erythematosus in mice and man].

Find a Location

Who is running the clinical trial?

Kyverna TherapeuticsLead Sponsor
6 Previous Clinical Trials
229 Total Patients Enrolled
1 Trials studying Lupus Nephritis
32 Patients Enrolled for Lupus Nephritis
MDStudy DirectorKyverna Therapeutics
929 Previous Clinical Trials
926,936 Total Patients Enrolled
2 Trials studying Lupus Nephritis
51 Patients Enrolled for Lupus Nephritis

Media Library

Lupus Nephritis Clinical Trial 2023: KYV-101 Highlights & Side Effects. Trial Name: NCT05938725 — Phase 1 & 2
KYV-101 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05938725 — Phase 1 & 2
~17 spots leftby Aug 2025
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