Primary Outcome Measures: Area under the curve (AUC) forTQB2303 and rituximab concentrations \[ Time Frame: 85 days \] Secondary Outcome Measures: The Maximum Concentration (Cmax) of the TQB2303 and rituximab \[ Time Frame: 85 days \] The area under the plasma concentration-time curve from 0 to inf (infinite) time (AUC0-∞); The time to reach the maximum plasma concentration after treatment (Tmax) Total clearance (CL); Elimination of half-life (t1 / 2); Apparent distribution volume (Vd).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
122
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
RECRUITINGFirst Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
RECRUITINGAUC
Area under the curve (AUC) forTQB2303 and rituximab concentrations
Time frame: 85 days
Cmax
The Maximum Concentration (Cmax) of the TQB2303 and rituximab
Time frame: 85 days
AUC0-∞
The area under the plasma concentration-time curve from 0 to inf (infinite) time
Time frame: 85 days
Tmax
The time to reach the maximum plasma concentration after treatment
Time frame: 85 days
CL
Total clearance
Time frame: 85 days
t1/2
Elimination of half-life
Time frame: 85 days
Vd
Apparent distribution volume
Time frame: 85 days
Evaluation of immunogenicity
Anti-drug antibody (ADA), neutralizing antibody (Nab detection when ADA positive)
Time frame: 85 days
Change of CD19+ CD20+ B-cells from baseline
Change of CD19+ CD20+ B-cells from baseline
Time frame: 85 days
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