A Phase 3 interventional study of TR115 and Investigator's Choice in PTCL and NK T-Cell Lymphoma, sponsored by Tarapeutics Science Inc.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Tarapeutics Science Inc. · Phase 3, Interventional, and Treatment
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.
179 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 32 are open to participants now.
This study's planned enrollment of 180 is above the median of 34 across 161 interventional studies indexed under Lymphoma, Extranodal NK-T-Cell.
Browse Lymphoma, Extranodal NK-T-Cell studies →Tarapeutics Science Inc. is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: TR115
Drug: Investigator's Choice
TR115 will be administered orally twice daily until documented disease progression, unacceptable toxicity, withdrawal of consent, death, or study discontinuation.
Investigator's choice treatment with chidamide, golidocitinib, mitoxantrone hydrochloride liposome, or gemcitabine hydrochloride administered according to the respective approved prescribing information.
Progression-Free Survival (PFS)
Assessed by Independent Review Committee (IRC) per Lugano 2014 criteria
Time frame: From randomization to disease progression or death from any cause, whichever occurs first, assessed up to 36 months.
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame: From randomization to death from any cause, assessed up to 36 months.
Objective Response Rate (ORR)
Proportion of participants achieving complete response (CR) or partial response (PR) as assessed by Independent Review Committee (IRC) and investigator according to Lugano 2014 criteria.
Time frame: Up to 36 months
Disease Control Rate (DCR)
Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) as assessed by IRC and investigator according to Lugano 2014 criteria.
Time frame: Up to 36 months
Duration of Response (DOR)
Time from first documented response (CR or PR) to disease progression or death from any cause, whichever occurs first, as assessed by IRC and investigator according to Lugano 2014 criteria.
Time frame: From first documented response to disease progression or death, assessed up to 36 months.
Time to Response (TTR)
Time from randomization to first documented response (CR or PR) as assessed by IRC and investigator according to Lugano 2014 criteria.
Time frame: From randomization to first documented response, assessed up to 36 months.
Safety and Tolerability
Incidence of adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), Grade ≥3 AEs, treatment-related AEs, AEs leading to dose modification or discontinuation, and deaths, as assessed by investigators and summarized using MedDRA classification and CTCAE v6.0.
Time frame: From first dose of study treatment until 30 days after the last dose, or until initiation of new anti-cancer therapy, whichever occurs first, up to approximately 36 months.
Population Pharmacokinetics of TR115
Population pharmacokinetic analyses will be conducted using plasma concentration data collected from participants receiving TR115. A nonlinear mixed-effects modeling approach will be used to characterize the pharmacokinetic profile of TR115 and evaluate the effects of intrinsic and extrinsic covariates on pharmacokinetic characteristics.
Time frame: Pre-dose and approximately 2 hours (±6 minutes) post-dose on Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 3 Day 1, up to approximately 36 months.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Tarapeutics Science Inc.