NCT06886139

A Phase 2 Study of TRS005 in Patients With CD20-positive R/R DLBCL.

A Multicenter, Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of TRS005 in Patients With CD20-Positive Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (estimated)
• Sponsor: Zhejiang Teruisi Pharmaceutical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a multicenter, open-label, single-arm, Phase II Study. Patients with CD20 positive recurrent or refractory diffuse large B-cell lymphoma and had failed ≥2 prior lines of standard treatment will be recruited. The purpose of this trial is to evaluate the efficacy, safety, pharmacokinetic (PK) and immunogenicity characteristics of TRS005 via intravenous drip.

Detailed description

The participants were screened and examined according to the protocol before enrollment. Participants received TRS005 at a dose of 1.8 mg/kg intravenously on day 1 of each 21-day cycle. The primary endpoints were objective response rate (ORR) assessed by Independent Review Committee (IRC). Participants were assessed for efficacy at the end of cycle 2, cycle 4, cycle 6 and every 4 subsequent cycles (each cycle is 21 days). Tumor responses were assessed by computerized tomography (CT) or positron emission tomography-computerized tomography (PET-CT) scanning per the Lugano 2014 criteria. The safety were assessed per the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Conditions

• CD20-positive Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	TRS005	Recombinant anti-CD20 monoclonal antibody-MMAE conjugte for injection. To be used under medical supervision.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-01-01
• Completion: 2027-09-01
• First posted: 2025-03-20
• Last updated: 2025-08-22

Locations

1 site across 1 country: China