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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kyverna TherapeuticsLead Sponsor

5 Previous Clinical Trials

208 Total Patients Enrolled

1 Trials studying Lupus Nephritis

32 Patients Enrolled for Lupus Nephritis

MDStudy DirectorKyverna Therapeutics

915 Previous Clinical Trials

924,698 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the potential level of danger associated with KYV-101 CAR-T cells combined with lymphodepletion conditioning for patients?

"Due to the limited evidence on KYV-101 CAR-T cells with lymphodepletion conditioning, our team at Power assigned it a score of 1 for safety. This is in accordance with its designation as a Phase 1 clinical trial, meaning that data regarding efficacy and safety is scarce."

Answered by AI

Are there any open slots in this research initiative for participants?

"Affirmative. The information on clinicaltrials.gov confirms the ongoing recruitment for this study, which was originally published on April 28th 2023 and updated most recently on July 7th 2021. A total of 12 patients are being sought out by two sites participating in the experiment."

Answered by AI

What is the total participant count for this empirical research?

"Affirmative. According to the information found on clinicaltrials.gov, this research initiative is currently seeking volunteers for participation; it was first posted April 28th 2023 and its most recent update took place July 7th 2023. To date, 12 patients have been recruited from 2 separate medical sites."

Answered by AI

What are the key goals of this research endeavor?

"According to Kyverna Therapeutics, the sponsor of this study, the primary outcome is Frequency of dose limiting toxicities at each dose level and will be monitored across a span of 24 months. In addition, secondary objectives include measuring pharmacodynamics (PD) through serum cytokine levels; evaluating disease related biomarkers with complement C3 & C4 in serum; and gauging efficacy which can be determined by tracking time from first achieved CRR to illness exacerbation or trial termination."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis

2023. "A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05938725.

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