NCT05395533

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

A Multicenter, Single-arm, Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effectiveness of TRS005 in Patients With Relapsed or Refractory CD20-positive B-NHL

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Zhejiang Teruisi Pharmaceutical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The subjects were screened and examined according to the protocol before enrollment. The dose of the enrolled subjects was increased according to the following 6 dose groups: 0.1mg/kg, 0.5mg/kg, 1.0mg/kg, 1.5mg/kg, 1.8mg/kg, 2.1mg/kg. The incremental process is divided into groups according to the principle of 3 + 3 dose increment. The subjects randomly receive intravenous drip of TRS005 in chronological order. Each subject first carries out a single dose study, and then carries out multiple continuous doses. The first dose is given once in D1. After 21 days of observation, it is decided whether to continue multiple continuous doses according to the situation. They are given once in C2D1, C3D1, C4D1, C5D1, C6D1, or more cycles respectively, and received treatment until progressive disease or unacceptable toxicity. During the dose escalation process, the investigators will perform dose expansion according to the clinical benefits of different dose groups.

Conditions

• CD20-positive B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Recombinant CD20 monoclonal antibody-MMAE conjugte for injection	The dose of the enrolled subjects was increased according to the following 6 dose groups: 0.1mg/kg, 0.5mg/kg, 1.0mg/kg, 1.5mg/kg, 1.8mg/kg, and 2.1mg/kg.

Timeline

• Start date: 2020-09-08
• Primary completion: 2025-07-31
• Completion: 2025-12-31
• First posted: 2022-05-27
• Last updated: 2025-06-25

Locations

6 sites across 1 country: China