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)

Description

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

Conditions

Chronic Kidney Disease (CKD)

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Study Overview

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Study Details

Study overview

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

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

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)

Condition
Chronic Kidney Disease (CKD)
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Orange

University of California Irvine, Orange, California, United States, 92868

San Francisco

Connie Frank Transplant Center at UCSF, San Francisco, California, United States, 94143

New Haven

Yale University of Medicine, New Haven, Connecticut, United States, 06520

Chicago

Comprehensive Transplant Center, Chicago, Illinois, United States, 60611

Baltimore

John Hopkins Hospital, Baltimore, Maryland, United States, 21224

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

New York

New York University Langone Health, New York, New York, United States, 10016

Philadelphia

Penn Transplant Institute, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Has Chronic Kidney Disease (CKD) requiring hemodialysis, and awaiting kidney transplant on the United Network for Organ Sharing (UNOS), with a cPRA ≥99.9%, or those with a cPRA \>98% (98.1% to 99.8%) who have spent 5 years or longer on the waitlist
  • 2. Adequate hematologic and adequate hepatic function as defined in the protocol
  • 3. Willing and able to comply with clinic visits and study-related procedures
  • 1. Current or active malignancy not in remission for at least 1 year
  • 2. Central nervous system (CNS) pathology or history of CNS neurodegenerative or movement disorders
  • 3. Patients who have had their spleen removed, including patients with functional asplenia
  • 4. Patients who have received a stem cell transplantation within 5 years
  • 5. Use of investigational agents within 8 weeks or 5 half-lives of study drug administration (whichever is larger)
  • 6. Total plasma IgG \<300 mg/dL at screening
  • 7. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone (or anti-inflammatory equivalent) within 72 hours of start of study drug administration
  • 8. Received a calcineurin inhibitor (eg, tacrolimus, cyclosporine) within 30 days of study drug administration
  • 9. Received cyclophosphamide, rituximab, obinutuzumab, other anti-CD20 or B cell-depleting agents, or proteasome inhibitors or anti-CD38 therapies (eg, isatuximab, daratumumab) within 12 months of study drug administration
  • 10. Prior treatment with any anti-BCMA antibody (including antibody drug conjugate or bsAb) or BCMA-directed CAR-T cell therapy, as described in the protocol
  • 11. Has received a COVID-19 vaccination, as described in the protocol

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Regeneron Pharmaceuticals,

Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

2027-01-06