A multi-center, open-label, randomized, parallel-controlled phase II study comparing pharmacokinetic, pharmacodynamics and safety of ripertamab (SCT400) to rituximab (MabThera^®) in patients with CD20-positive B-cell non-Hodgkin lymphoma.

ABSTRACT:

Objective

This multi-center, open-label, randomized, parallel-controlled phase II study aimed to compare the pharmacokinetics (PK), pharmacodynamics (PD) and safety profile of ripertamab (SCT400), a recombinant anti-CD20 monoclonal antibody, to rituximab (MabThera^®) in patients with CD20-positive B-cell non-Hodgkin lymphoma (NHL).

Methods

Patients with CD20-positive B-cell NHL who achieved complete remission or unconfirmed complete remission after standard treatment were randomly assigned at a 1:1 ratio to receive a single dose of ripertamab (375 mg/m²) or rituximab (MabThera^®, 375 mg/m²). PK was evaluated using area under the concentration-time curve (AUC) from time 0 to d 85 (AUC_{0-85 d}), AUC from time 0 to week 1 (AUC<

SUBMITTER: Han X 

PROVIDER: S-EPMC9829503 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature