The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
University of California San Diego StudyCoordinator:CHCD122A2101
La Jolla, California, United States
St. Francis Cancer Research Foundation
Beech Grove, Indiana, United States
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Div Of HematologicMalignancies
Baltimore, Maryland, United States
OSU Medical Center/Arthur G. James Cancer Hospital StudyCoordinator:CHCD122A2101
Columbus, Ohio, United States
to determine the maximum tolerated dose (MTD)
Time frame: between study Day 1 and study Day 50
to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients
Time frame: between study Day 1 and study termination
To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients
Time frame: between study Day 1 and study termination
To characterize peripheral blood CD40 occupancy on CD5/CD19 (CLL) cells and CD5/CD19 cell depletion activity (pharmacodynamics) of HCD122 at each dose level in dose escalation patients
Time frame: between study Day 1 and study termination
To assess preliminary anti-tumor activity of HCD122 in dose escalation patients
Time frame: between study Day 1 and study termination
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MD Anderson Cancer Center/University of Texas Dept of MD Anderson CancerCent
Houston, Texas, United States