This is a Phase Ib, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of Efmarodocokin Alfa and to make a preliminary assessment of activity of Efmarodocokin Alfa in combination with standard-of-care (SOC) in the prevention of acute graft-versus-host disease (aGVHD) in participants undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
18
Efmarodocokin Alfa will be administered intravenously (IV) per the dosage specified in each dose escalation cohort.
City of Hope
Duarte, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
University of Miami Miller School of Medicine; Clinical Reseach Building
Miami, Florida, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas Med Ctr; Int med/Allgy/Immun/Rheum
Kansas City, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Number of Participants with Adverse Events by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)
Time frame: From Baseline up to 365 days
Change from Baseline in Respiratory Rate Over Time
Time frame: From Baseline up to 139 days
Change from Baseline in Oxygen Saturation Over Time
Time frame: From Baseline up to 139 days
Change from Baseline in Pulse Rate Over Time
Time frame: From Baseline up to 139 days
Change from Baseline in Systolic Blood Pressure Over Time
Time frame: From Baseline up to 139 days
Change from Baseline in Diastolic Blood Pressure Over Time
Time frame: From Baseline up to 139 days
Change from Baseline in Body Temperature Over Time
Time frame: From Baseline up to 139 days
Number of Participants with Laboratory Abnormalities in Hematology Tests
Time frame: From Baseline up to 139 days
Number of Participants with Laboratory Abnormalities in Blood Chemistry Tests
Time frame: From Baseline up to 139 days
Serum Concentration of Efmarodocokin Alfa at Specified Timepoints
Time frame: At predefined timepoints from Baseline until Day 139
Number of Participants with Anti-Drug Antibodies (ADAs) at Baseline and During the Study
Time frame: At predefined timepoints from Baseline until Day 139
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