MedTrace Logo

A Phase I/II Study of TRS005 in Combination With Cyclophosphamide, Doxorubicin, and Prednisone（T-CHP） in Previously Untreated Patients With CD20-positive DLBCL

NCT07035379 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-08-22

No results posted yet for this study

Summary

This trial is a multicenter, open-label, single-arm, dose-escalation and dose-expansion clinical trial. The dose was increased according to the "3 + 3" rule. Patients with previously untreated patients with CD20-positive DLBCL were selected to evaluate the safety, tolerance (DLT, MTD), pharmacokinetics, and anti-tumor activity of TRS005 in combination with standard doses of cyclophosphamide, doxorubicin, and prednisone（T-CHP） by intravenous drip every 3 weeks.

Conditions

  • Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

DRUG

TRS005

TRS005 will be administered at a starting dose of 0.8mg/kg IV every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles (up to 8).

DRUG

Cyclophosphamide

Cyclophosphamide will be administered at 750 milligrams per square meter (mg/m\^2) IV every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles.

DRUG

Doxorubicin

Doxorubicin will be administered at 50 mg/m\^2 IV every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles.

DRUG

Prednisolone

Prednisolone will be administered at 100 mg orally daily for 5 days every 3 weeks (starting from Cycle 1 Day 1), for 6 cycles.

Sponsors & Collaborators

  • Zhejiang Teruisi Pharmaceutical Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-09-01
Completion
2028-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07035379 on ClinicalTrials.gov