Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
181
Beijing cancer hospital
Beijing, Beijing Municipality, China
Peking University third hospital
Beijing, Beijing Municipality, China
The 307th Hospital of Military Medical Sciences
Beijing, Beijing Municipality, China
AUC0-inf of IBI301 and rituximab
Time frame: 91 days
Peak Plasma Concentration (Cmax)
Time frame: 91 days
Percentage and absolute value of CD19+
Time frame: 91 days
Percentage and absolute value of CD20+ B-cell
Time frame: 91 days
Positive rate of ADA
Time frame: 91 days
Positive rate of NAb
Time frame: 91 days
Safety profiles
Including AE type、incidence rate、severity and drug- related
Time frame: up to 1 year
Area under the plasma concentration versus time curve (AUC)
Time frame: 91days
AUC(0-t) of IBI301 and rituximab
Time frame: 91 days
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Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu province people's hospital
Nanjing, Jiangsu, China
West China Hospital,Sichuan University
Chengdu, Sichuan, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
...and 2 more locations