drugset / Trial / NCT05395533

A Phase 1 Study of TRS005 in Patients With R/R CD20-positive B-NHL.

NCT05395533

Phase 1 Active not recruiting 147 enrolled Zhejiang Teruisi Pharmaceutical Inc.
NaSingle-groupOpen-labelTreatment

Summary

This trial is a multicenter, open, single arm, dose increasing and extended clinical trial. The dose was increased according to the "3 + 3" rule. Patients with recurrent or refractory CD20 positive B-cell non-Hodgkin's lymphoma were selected to evaluate the safety, tolerance (DLT, MTD) and pharmacokinetic (PK) characteristics of TRS005 by intravenous drip.

Timeline

Start
2020-09-08
Primary completion
2025-07-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject TRS005 Monoclonal antibody 0.1 mg/kg Intravenous
Subject TRS005 Monoclonal antibody 0.5 mg/kg Intravenous
Subject TRS005 Monoclonal antibody 1 mg/kg Intravenous
Subject TRS005 Monoclonal antibody 1.5 mg/kg Intravenous
Subject TRS005 Monoclonal antibody 1.8 mg/kg Intravenous
Subject TRS005 Monoclonal antibody 2.1 mg/kg Intravenous