RECRUITING

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)

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Conditions

Chronic Kidney Disease (CKD)Kidney TransplantHemodialysisDesensitizationHuman Leukocyte Antigen (HLA)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2022-08-02
Study Completion:2027-01-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05092347

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Adequate hematologic and adequate hepatic function as defined in the protocol
  3. 3. Willing and able to comply with clinic visits and study-related procedures
  1. 1. Current or active malignancy not in remission for at least 1 year
  2. 2. Central nervous system (CNS) pathology or history of CNS neurodegenerative or movement disorders
  3. 3. Patients who have had their spleen removed, including patients with functional asplenia
  4. 4. Patients who have received a stem cell transplantation within 5 years
  5. 5. Use of investigational agents within 8 weeks or 5 half-lives of study drug administration (whichever is larger)
  6. 6. Total plasma IgG \<300 mg/dL at screening
  7. 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. 8. Received a calcineurin inhibitor (eg, tacrolimus, cyclosporine) within 30 days of study drug administration
  9. 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. 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. 11. Has received a COVID-19 vaccination, as described in the protocol

Contacts and Locations

Study Contact

Clinical Trials Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California Irvine
Orange, California, 92868
United States
Connie Frank Transplant Center at UCSF
San Francisco, California, 94143
United States
Yale University of Medicine
New Haven, Connecticut, 06520
United States
Comprehensive Transplant Center
Chicago, Illinois, 60611
United States
John Hopkins Hospital
Baltimore, Maryland, 21224
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
New York University Langone Health
New York, New York, 10016
United States
Penn Transplant Institute
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-02
Study Completion Date2027-01-06

Study Record Updates

Study Start Date2022-08-02
Study Completion Date2027-01-06

Terms related to this study

Keywords Provided by Researchers

  • Kidney Transplant
  • Hemodialysis
  • Desensitization
  • Human Leukocyte Antigen (HLA)

Additional Relevant MeSH Terms

  • Chronic Kidney Disease (CKD)