drugset / Trial / NCT03332121

B001 in Patients With CD20 Positive B-cell Non Hodgkin's Lymphoma

NCT03332121 ↗

Phase 1 Completed 30 enrolled Shanghai Pharmaceuticals Holding Co., Ltd
NaSingle-groupOpen-labelTreatment

Summary

It's the first-in-human study of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection (B001). The main purpose of this study is to explore the safety and tolerance of B001 for patients with CD20 positive B-cell non Hodgkin's lymphoma. It will also explore the PK/PD manner and ORR in this study.

Timeline

Start
2018-03-22
Primary completion
2020-11-30
Completion
2021-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject B001 Monoclonal antibody 350 mg Intravenous
Subject B001 Monoclonal antibody 700 mg Intravenous
Subject B001 Monoclonal antibody 1000 mg Intravenous
Subject B001 Monoclonal antibody 1500 mg Intravenous
Subject B001 Monoclonal antibody 2000 mg Intravenous