drugset / Trial / NCT03218072

A Study to Evaluate Safety, Tolerability, PK and PD of HLX01 in Patients With CD20-positive B-cell Lymphomas

NCT03218072 ↗

Phase 1 Completed 12 enrolled Shanghai Henlius Biotech
Non-randomizedParallel-groupOpen-labelTreatment

Summary

To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a potential rituximab biosimilar) in patients with CD20-positive B-cell lymphomas.

Timeline

Start
2014-05-04
Primary completion
2015-01-31
Completion
2015-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX01 Monoclonal antibody 250 mg/m2 Intravenous
Subject HLX01 Monoclonal antibody 375 mg/m2 Intravenous
Subject HLX01 Monoclonal antibody 500 mg/m2 Intravenous