The primary objective of the study is to assess the pharmacokinetic (PK) similarity of SCT400 versus rituximab (MabThera®) in patients with CD20+ B-cell Non-Hodgkin's Lymphoma. The secondary objective of the study is to evaluate the pharmacodynamics (PD) and safety of SCT400 versus rituximab (MabThera®), as well as the presence of human anti-chimeric antibodies (HACA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGArea under the curve (AUC) for SCT400 and rituximab concentrations
Time frame: 85 days
AUC for SCT400 and rituximab concentrations
Time frame: 1 week ,2 weeks, 4 weeks, 8 weeks and 12 weeks
Maximum observed concentration of the SCT400 and rituximab
Time frame: 85 days
Change from baseline of CD19+ , CD20+ B-cells
Time frame: 85 days
Comparison of AEs between the two study arms
Time frame: 85 days
Comparison of HACA between the two study arms
Time frame: 85 days
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