Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at UC Irvine UCSF
Dates
study started
completion around

Description

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

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

Keywords

Chronic Kidney Disease (CKD), Kidney Transplant, Hemodialysis, Desensitization, Human Leukocyte Antigen (HLA), Kidney Diseases, Chronic Renal Insufficiency, Vonsetamig

Eligibility

You can join if…

Open to people ages 18-70

  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

You CAN'T join if...

  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

Note: Other protocol defined inclusion / exclusion criteria apply

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • Connie Frank Transplant Center at UCSF accepting new patients
    San Francisco California 94143 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT05092347
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 56 study participants
Last Updated