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)
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
56 participants
Aug 2, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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
Exclusion Criteria11
- 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
Interventions
Administered by intravenous (IV) infusion
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT05092347