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

A Randomized, Controlled, Open-label, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of TR115 in Patients With Relapsed and/or Refractory Peripheral T/NK-Cell Lymphoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PTCL; NK T-Cell Lymphoma
• Intervention / Treatment: Drug: TR115; Drug: Investigator's Choice

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yang Shu; Phone Number: 86 13918983465; Email: shuyang@tarapeutics.com

Study Locations

• China
  • Beijing Municipality
    • Beijin, Beijing Municipality, China, 100142
      • Peking University Cancer Hospital
      • Contact: Yuqin Song; Phone Number: 86 10-88196118; Email: SongYQ_VIP@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed peripheral T-cell lymphoma (PTCL), including PTCL-NOS, AITL, ALCL, or NKTCL
• Received at least one prior systemic therapy and prior exposure to at least one novel agent (e.g., chidamide, pralatrexate, brentuximab vedotin, etc.) or refractory/intolerant to such therapies
• Age ≥18 years
• ECOG performance status 0-1
• At least one measurable lesion per Lugano 2014 criteria (lymph node ≥1.5 cm in longest diameter or extranodal lesion ≥1.0 cm)
• Adequate organ function, defined as: ANC ≥1.5 × 10⁹/L, Platelets ≥100 × 10⁹/L, Hemoglobin ≥100 g/L, Total bilirubin ≤1.5 × ULN, ALT/AST ≤2.5 × ULN (≤5 × ULN if liver involvement), Creatinine clearance ≥50 mL/min (Cockcroft-Gault), LVEF ≥50%, QTcF <450 ms (male), <470 ms (female)
• Willingness to provide archival or fresh tumor tissue
• Life expectancy ≥3 months

Exclusion Criteria:

• Prior treatment with EZH2 or EZH1/2 inhibitors resulting in disease progression (intolerance permitted)
• Known central nervous system involvement of lymphoma
• Active uncontrolled infection requiring systemic therapy
• Significant or uncontrolled cardiovascular disease
• Prior allogeneic stem cell transplantation or autologous stem cell transplantation within 90 days prior to first dose
• Pregnancy or lactation, or unwillingness to use effective contraception
• Other malignancies within 5 years, except adequately treated basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, or thyroid carcinoma
• Patients planned to receive mitoxantrone liposomal therapy with prior cumulative doxorubicin exposure ≥350 mg/m² (or equivalent anthracycline exposure)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Investigator's Choice	Drug: Investigator's Choice; Investigator's choice treatment with chidamide, golidocitinib, mitoxantrone hydrochloride liposome, or gemcitabine hydrochloride administered according to the respective approved prescribing information.
Experimental: TR115 tablet	Drug: TR115; TR115 will be administered orally twice daily until documented disease progression, unacceptable toxicity, withdrawal of consent, death, or study discontinuation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	Assessed by Independent Review Committee (IRC) per Lugano 2014 criteria	From randomization to disease progression or death from any cause, whichever occurs first, assessed up to 36 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time from randomization to death from any cause.	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.	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.	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.	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.	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.	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.	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.

Collaborators and Investigators

• Sponsor: Tarapeutics Science Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 30, 2030

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: June 6, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, Extranodal NK-T-Cell
• Other Study ID Numbers: TR115-CN-PIII-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No