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A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
Sponsor: Biocon Limited
Summary
This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of EQ001 in subjects with Acute Graft Versus Host Disease (aGVHD).
Official title: A Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of EQ001 in Subjects With Newly Diagnosed Acute Graft Versus Host Disease
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2019-07-15
Completion Date
2022-11-21
Last Updated
2026-06-11
Healthy Volunteers
No
Interventions
EQ001
Itolizumab \[Bmab 600\])
EQ001 Placebo
EQ001 Placebo
Locations (16)
City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of Florida Health Shands Hospital
Gainesville, Florida, United States
University of Miami - Miller School of Medicine
Miami, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan - C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Washington University and Barnes Jewish Heart & Vascular Center
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
TriStar Centennial Medical Center (SCRI)
Nashville, Tennessee, United States
Intermountain Healthcare
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States