It's the first-in-human study of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection (B001). The main purpose of this study is to explore the safety and tolerance of B001 for patients with CD20 positive B-cell non Hodgkin's lymphoma. It will also explore the PK/PD manner and ORR in this study.
Phase I dose escalation study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
4 times intravenous injection totally,dosing at Day1,Day35,Day56,Day77
The second affiliated hospital of Guangzhou medical university
Guangzhou, Guangdong, China
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, Tianjin Municipality, China
Safety of B001 as assessed by adverse reactions and events
Incidence and intensity of adverse events according to NCI CTCAE 4.03 associated with increasing doses of B001
Time frame: 42 days
Concentration-time curve of B001
Measure the concentration of B001 in serum at different time point to get a concentration-time curve.
Time frame: 112 days
PD results of B001
Measure the number of CD19 positive B cell in peripheral blood
Time frame: 112 days
Immunogenicity of B001
Content analysis of anti-B001 antibody
Time frame: 112 days
ORR of B001
Objective response rate according to Response Criteria for Lymphoma(not including PET)and CLL Response Criteria
Time frame: 112 days
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