This study is an open-label, multi-center, dose-ranging study to characterize the safety, tolerability, preliminary efficacy, and PK/PD of up to four dose levels of BNZ-1 administered weekly by IV infusion to adults diagnosed with Large Granular Lymphocyte (LGL) Leukemia or refractory Cutaneous T-cell Lymphoma (CTCL).
This study is an open-label, multi-center, dose-ranging study to characterize the safety, tolerability, preliminary efficacy, and PK/PD of up to four dose levels of BNZ-1 administered weekly by IV infusion to adults diagnosed with LGL or CTCL. The study has 5 periods: * Screening Period * 4-week Treatment Period * 3-month Treatment Extension Period * Long-term Extension Period (open-ended) * 6-week Follow-up Period Subjects will be screened for eligibility within 30 days of study Day 1 (first dosing day of the 4-Week Treatment Period).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Injectable PEGylated peptide antagonist that binds to the common gamma chain (γc) signaling receptor for the cytokines interleukin (IL)-2, IL-9, and IL-15
City of Hope National Medical Center
Duarte, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
The James Cancer Center, Ohio State University
Columbus, Ohio, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Incidence, severity and relationship of treatment-emergent adverse events
Time frame: 1 month
Incidence, severity and relationship of treatment-emergent adverse events
Time frame: 4 months
Pharmacodynamics
Flow cytometry: Change from baseline over time for Tregs, NK cells and CD8+ central memory T-cells
Time frame: 16 weeks
Single-dose and steady-state Cmax
Plasma levels of BNZ-1 will be measured after the 1st and last doses
Time frame: 16 weeks
Single-dose and steady-state AUC
Plasma levels of BNZ-1 will be measured after the 1st and last doses
Time frame: 16 weeks
Steady-state Elimination half-life (t1/2)
Plasma levels of BNZ-1 will be measured after the last dose
Time frame: 16 weeks
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