An open label, ascending dose study for adult subjects with T-cell Large Granular Lymphocytic Leukemia (T-LGLL)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Given subcutaneous injection
City of Hope
Duarte, California, United States
University of Southern California
Los Angeles, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Incidence, nature, and severity of treatment-emergent AEs and SAEs as determined by NCI CTCAE v5.0
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (Hematology)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (Chemistry)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (Coagulation)
Includes the following coagulation labs: INR and aPTT
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (Complement)
Includes the following complement labs: C3 and CH50
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (Cytokines)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (CMV Viral Load)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (EBV Viral Load)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in ECG (Rhythm)
Time frame: Through Study Completion an average of 48 weeks
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Change from baseline in ECG (Heart Rate)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in ECG parameters
Includes the following ECG parameters: RR interval, PR interval, QRS interval, QT interval, QT interval corrected by Bazett's formula, and QTcF
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in vital sign (Systolic and diastolic blood pressure)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in vital sign (temperature)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in vital sign (respiratory rate)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in vital sign (pulse rate)
Time frame: Through Study Completion an average of 48 weeks
Percentage of subjects demonstrating overall response (defined as total number of subjects with CR or PR) at all time points assessed
Time frame: Day 1 and throughout the 48 weeks of follow up
Percentage of subjects demonstrating complete response at all time points assessed
A complete response is defined by normalization of hemoglobin, neutrophil and platelet levels without transfusion
Time frame: Day 1 and throughout the 48 weeks of follow up
Percentage of subjects demonstrating partial response at all time points assessed
A partial response is defined by improvement in any of the following criteria but not all: hemoglobin, neutrophil and platelet levels without transfusion
Time frame: Day 1 and throughout the 48 weeks of follow up
Duration of response at all time points assessed
Time frame: Day 1 and throughout the 48 weeks of follow up
Overall survival at Week 48
Time frame: Day 1 and throughout the 48 weeks of follow up
The change from baseline in levels of KLRG1 expressing lymphocytes over time
Time frame: Day 1 and throughout the 48 weeks of follow up
The change from baseline in levels of T-LGL counts over time
Time frame: Day 1 and throughout the 48 weeks of follow up
The change from baseline in levels of lymphocyte subsets over time
Time frame: Day 1 and throughout the 48 weeks of follow up
The maximum serum concentration [CMax] of ABC008
Time frame: Day 1 and throughout the 48 weeks of follow up
The time to maximum concentration [TMax] of ABC008
Time frame: Day 1 and throughout the 48 weeks of follow up
The area under the concentration-time curve [AUC] of ABC008
Time frame: Day 1 and throughout the 48 weeks of follow up
The apparent clearance [CL/F] of ABC008
Time frame: Day 1 and throughout the 48 weeks of follow up
The apparent volume of distribution [Vd/F] of ABC008
Time frame: Day 1 and throughout the 48 weeks of follow up
The elimination half-life [t½] of ABC008
Time frame: Day 1 and throughout the 48 weeks of follow up