To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a potential rituximab biosimilar) in patients with CD20-positive B-cell lymphomas.
This was a phase Ia, multicenter, open-label, dose-escalation clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics of HLX01 injection in patients with CD20-positive B-cell lymphomas.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
a potential rituximab biosimilar
AEs
The type, severity and incidence of adverse events
Time frame: From First infusion to Day 90
SAEs
Thetype, severity and incidence of SAEs
Time frame: From First infusion to Day 90
AUC0-inf
Area under the serum concentration-time curve from time 0 extrapolated to infinity
Time frame: From First administration to Day 90
Cmax
Maximum serum concentration
Time frame: From First administration to Day 90
t1/2
terminal half-life
Time frame: From First administration to Day 90
CD19 positive B cells
The count of CD19 positive in peripheral blood
Time frame: From First administration to Day 90
CD20 positive B cells
The count of CD20 positive in peripheral blood
Time frame: From First administration to Day 90
Antidrug antibodies of HLX01
The concentration of anti-HLX01 in serum
Time frame: From First administration to Day 90
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.