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ACTIVE NOT RECRUITING
NCT05395533
PHASE1

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

Sponsor: Zhejiang Teruisi Pharmaceutical Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

147

Start Date

2020-09-08

Completion Date

2025-12-31

Last Updated

2025-06-25

Healthy Volunteers

No

Interventions

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.

Locations (6)

Chinese Academy of Medical Sciences, Cancer Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center (SYSUCC)

Guangzhou, Guangdong, China

Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Tianjin Medical University Cancer Institute & Hospital (TMUCIH)

Tianjin, Tianjin Municipality, China