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OpenTrials
Active, Not Recruiting

NCT Number: NCT05092347

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)

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Note: Other protocol defined inclusion / exclusion criteria apply

Treatment and study plan

Vonsetamig

Drug

Administered by intravenous (IV) infusion

Other names: BCMAxCD3, REGN5459

Primary outcomes

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

    Time frame: Up to approximately 6 weeks

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

    Time frame: Up to 78 weeks

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

Secondary outcomes

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

    Time frame: Up to 78 weeks

    Clinically meaningful reduction in anti-HLA alloantibodies are defined as either:

    • Reduction in Calculated panel-reactive antibody (cPRA) from baseline, or
    • Reduction in the peak (immunodominant) anti-HLA mean fluorescence intensity (MFI) to <5,000, or by ≥50% by Single antigen bead (SAB) assay
  2. Maximum reduction in the peak (immunodominant) MFI of anti-HLA alloantibodies from baseline

    Time frame: Up to 78 weeks

  3. Percent change from baseline in the peak (immunodominant) MFI

    Time frame: Up to 78 weeks

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

    Time frame: Up to 78 weeks

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

    Time frame: Up to 78 weeks

    Defined as peak anti-HLA alloantibody MFI <5,000 or ≥50% reduction

  6. Time to maximal reduction in anti-HLA alloantibody levels by SAB assay

    Time frame: Up to 78 weeks

    Defined as peak anti-HLA alloantibody MFI <5,000 or ≥50% reduction

  7. Maximum reduction in cPRA from baseline

    Time frame: Up to 78 weeks

  8. Time to first clinically meaningful reduction in cPRA

    Time frame: Up to 78 weeks

  9. Time to maximal reduction in cPRA from baseline

    Time frame: Up to 78 weeks

  10. Duration of a reduction in peak anti-HLA alloantibody to MFI <5,000 or by ≥50% by SAB assay

    Time frame: Up to 78 weeks

  11. Duration of maximal reduction in anti-HLA alloantibody MFI by SAB assay

    Time frame: Up to 78 weeks

  12. Duration of maximal reduction in cPRA by SAB assay

    Time frame: Up to 78 weeks

  13. Serum concentration of Immunoglobulin (Ig) classes over time

    Time frame: Up to 78 weeks

  14. Percent change from baseline of serum concentration of Ig classes

    Time frame: Up to 78 weeks

  15. Concentration of vonsetamig in serum over time

    Time frame: Up to 78 weeks

  16. Incidence of treatment-emergent anti-drug antibodies (ADAs) to vonsetamig over time

    Time frame: Up to 78 weeks

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 25, 2021
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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