RecruitingPhase 1Phase 2NCT05092347

A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA)

A Dose Escalation and Proof-of-Concept Study of Vonsetamig (BCMA × CD3 Bispecific Antibody) for Desensitization of Chronic Kidney Disease Patients in Need of Kidney Transplantation Who Are Highly Sensitized to Human Leukocyte Antigen


Sponsor

Regeneron Pharmaceuticals

Enrollment

56 participants

Start Date

Aug 2, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine whether vonsetamig will safely decrease anti-HLA antibodies to allow for kidney transplantation. Vonsetamig is being studied for treatment of patients in need of kidney transplantation who are highly sensitized to HLA. The study is looking at several other research questions, including: * Side effects that may be experienced from taking vonsetamig * How vonsetamig works in the body * How much vonsetamig is present in the blood * If vonsetamig works to lower levels of antibodies to HLA


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called vonsetamig in people with chronic kidney disease (CKD) who need a kidney transplant but are "highly sensitized" — meaning their immune system has developed so many antibodies that it is very difficult to find a compatible donor kidney. The drug aims to reduce those antibodies, making transplant possible. **You may be eligible if...** - You have chronic kidney disease requiring hemodialysis (dialysis through a machine) - You are on the kidney transplant waiting list and have a very high level of antibodies (cPRA ≥ 99.9%, or ≥ 98% with 5+ years on the waitlist) - Your blood and liver function meet requirements - You are willing and able to attend clinic visits **You may NOT be eligible if...** - You have an active cancer not in remission for at least 1 year - You have had your spleen removed - You received a stem cell transplant within the past 5 years - Your immune system function (IgG levels) is very low - You are currently on high-dose steroids or certain immune-suppressing drugs - You have significant nervous system disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVonsetamig

Administered by intravenous (IV) infusion


Locations(10)

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California Irvine

Orange, California, United States

Connie Frank Transplant Center at UCSF

San Francisco, California, United States

Yale University of Medicine

New Haven, Connecticut, United States

Medstar Georgetown Transplant Institute - 2-PHC

Washington D.C., District of Columbia, United States

Comprehensive Transplant Center

Chicago, Illinois, United States

John Hopkins Hospital

Baltimore, Maryland, United States

University of Minnesota

Minneapolis, Minnesota, United States

New York University Langone Health

New York, New York, United States

Penn Transplant Institute

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT05092347


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