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
Regeneron Pharmaceuticals
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
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion 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, as defined in the protocol 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 Key Exclusion Criteria: 1. Current or active malignancy not in remission for at least 1 year 2. Central nervous system (CNS) pathology…
Interventions
- DrugVonsetamig
Administered by intravenous (IV) infusion
Locations (10)
- Cedars-Sinai Medical CenterLos Angeles, California
- University of California IrvineOrange, California
- Connie Frank Transplant Center at UCSFSan Francisco, California
- Yale University of MedicineNew Haven, Connecticut
- Medstar Georgetown Transplant Institute - 2-PHCWashington D.C., District of Columbia
- Comprehensive Transplant CenterChicago, Illinois