drugset / Trial / NCT07639879

TR115 VS Investigator's Choice in Relapsed/Refractory Peripheral T/NK Cell Lymphoma

NCT07639879

Phase 3 Not yet recruiting 180 enrolled Tarapeutics Science Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open-label, multicenter Phase III study evaluating the efficacy and safety of TR115, an EZH2 inhibitor, versus investigator's choice (chidamide, golidocitinib, mitoxantrone liposome, or gemcitabine) in patients with relapsed and/or refractory peripheral T/NK-cell lymphoma. Approximately 180 patients will be randomized in a 1:1 ratio. The primary endpoint is progression-free survival (PFS) assessed by an Independent Review Committee (IRC). The key secondary endpoint is overall survival (OS). The study is being conducted at approximately 40 to 60 centers across China.

Timeline

Start
2026-07-30
Primary completion
2029-07-30
Completion
2030-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule
Subject Golidocitinib Small molecule
Subject Mitoxantrone Small molecule
Subject TR115 Unknown Oral
Subject Tucidinostat Small molecule