The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing schedule.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
GP2013
Investigative Site
Tachikawa, Tokyo, Japan
To evaluate safety of GP2013
Adverse events, laboratory abnormalities
Time frame: 12 weeks
Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013
Time frame: 12 weeks
Maximum observed concentration of GP2013
Time frame: 12 weeks
Time to reach maximum concentration of GP2013
Time frame: 12 weeks
Minimum (trough) observed concentration during each dosing interval of GP2013
Time frame: 12 weeks
Terminal elimination rate constant calculated as the slope of the linear regression of the terminal phase of the logarithmic concentration-time profile of GP2013
Time frame: 12 weeks
Elimination half-life associated with the terminal slope of GP2013
Time frame: 12 weeks
To evaluate efficacy of GP2013
Antitumor activity
Time frame: 12 weeks
To evaluate the incidence of immunogenicity (ADA formation) against GP2013
Immunogenicity (ADA formation)
Time frame: 12 weeks
To evaluate peripheral CD19+ B-cell count
CD19 + B-cell count
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Time frame: 12 weeks