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)

NCT05092347 | Recruiting Phase 1 FDA Drug

• 1 other identifier: R5459-RT-1944
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Chronic Kidney Disease (CKD)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse event(s) of interest (AEI) from the first dose through end of the safety observation period

  Up to approximately 6 weeks

• Incidence and severity of treatment-emergent adverse events (TEAE)s from the first study drug dose up to the end of the study

  TEAEs include adverse events of special interest (AESI) and serious adverse events (SAEs)

  Up to 78 weeks

Secondary Outcomes (16)

• Proportion of Participants with a clinically meaningful reduction in anti-HLA alloantibodies

  Up to 78 weeks

• Maximum reduction in the peak (immunodominant) MFI of anti-HLA alloantibodies from baseline

  Up to 78 weeks

• Percent change from baseline in the peak (immunodominant) MFI

  Up to 78 weeks

• Percent change from baseline in the sum of MFI of anti-HLA alloantibodies using the SAB assay

  Up to 78 weeks

• Time to first clinically meaningful reduction in anti-HLA alloantibody levels by SAB assay

  Up to 78 weeks

Study Arms (1)

Vonsetamig

EXPERIMENTAL

Drug: Vonsetamig

Interventions

Vonsetamig DRUG

Administered by intravenous (IV) infusion

Also known as: BCMAxCD3, REGN5459

Vonsetamig

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, as defined in the protocol
• Adequate hematologic and adequate hepatic function as defined in the protocol
• Willing and able to comply with clinic visits and study-related procedures

You may not qualify if:

• Current or active malignancy not in remission for at least 1 year
• Central nervous system (CNS) pathology or history of CNS neurodegenerative or movement disorders
• Patients who have had their spleen removed, including patients with functional asplenia
• Patients who have received a stem cell transplantation within 5 years
• Use of investigational agents within 8 weeks or 5 half-lives of study drug administration (whichever is larger)
• Total plasma IgG \<300 mg/dL at screening
• 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
• Received a calcineurin inhibitor (eg, tacrolimus, cyclosporine) within 30 days of study drug administration
• 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
• 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
• Has received a COVID-19 vaccination, as described in the protocol

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (10)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of California Irvine

Orange, California, 92868, United States

RECRUITING

Connie Frank Transplant Center at UCSF

San Francisco, California, 94143, United States

RECRUITING

Yale University of Medicine

New Haven, Connecticut, 06520, United States

RECRUITING

Medstar Georgetown Transplant Institute - 2-PHC

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Comprehensive Transplant Center

Chicago, Illinois, 60611, United States

RECRUITING

John Hopkins Hospital

Baltimore, Maryland, 21224, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

New York University Langone Health

New York, New York, 10016, United States

RECRUITING

Penn Transplant Institute

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: October 25, 2021
• Study Start: August 2, 2022
• Primary Completion (Estimated): November 22, 2027
• Study Completion (Estimated): November 22, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (10)