Vonsetamig
DrugAdministered by intravenous (IV) infusion
Other names: BCMAxCD3, REGN5459
NCT Number: NCT05092347
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
This study is active but is not currently recruiting participants.
18 year–70 year
All sexes
Interventional
Phase 1 / Phase 2
Cedars-Sinai Medical Center, Los Angeles, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined inclusion / exclusion criteria apply
Administered by intravenous (IV) infusion
Other names: BCMAxCD3, REGN5459
Time frame: Up to approximately 6 weeks
Time frame: Up to 78 weeks
TEAEs include adverse events of special interest (AESI) and serious adverse events (SAEs)
Time frame: Up to 78 weeks
Clinically meaningful reduction in anti-HLA alloantibodies are defined as either:
Time frame: Up to 78 weeks
Time frame: Up to 78 weeks
Time frame: Up to 78 weeks
Time frame: Up to 78 weeks
Defined as peak anti-HLA alloantibody MFI <5,000 or ≥50% reduction
Time frame: Up to 78 weeks
Defined as peak anti-HLA alloantibody MFI <5,000 or ≥50% reduction
Time frame: Up to 78 weeks
Time frame: Up to 78 weeks
Time frame: Up to 78 weeks
Time frame: Up to 78 weeks
Time frame: Up to 78 weeks
Time frame: Up to 78 weeks
Time frame: Up to 78 weeks
Time frame: Up to 78 weeks
Time frame: Up to 78 weeks
Time frame: Up to 78 weeks
Regeneron Pharmaceuticals
Industry
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
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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