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NCT Number: NCT07639879

TR115 VS Investigator's Choice in Relapsed/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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TR115

Drug

TR115 will be administered orally twice daily until documented disease progression, unacceptable toxicity, withdrawal of consent, death, or study discontinuation.

Investigator's choice

Drug

Investigator's choice treatment with chidamide, golidocitinib, mitoxantrone hydrochloride liposome, or gemcitabine hydrochloride administered according to the respective approved prescribing information.

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: From randomization to disease progression or death from any cause, whichever occurs first, assessed up to 36 months.

    Assessed by Independent Review Committee (IRC) per Lugano 2014 criteria

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From randomization to death from any cause, assessed up to 36 months.

    Time from randomization to death from any cause.

  2. Objective Response Rate (ORR)

    Time frame: Up to 36 months

    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.

  3. Disease Control Rate (DCR)

    Time frame: Up to 36 months

    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.

  4. Duration of Response (DOR)

    Time frame: From first documented response to disease progression or death, assessed up to 36 months.

    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.

  5. Time to Response (TTR)

    Time frame: From randomization to first documented response, assessed up to 36 months.

    Time from randomization to first documented response (CR or PR) as assessed by IRC and investigator according to Lugano 2014 criteria.

  6. Safety and Tolerability

    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.

    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.

  7. Population Pharmacokinetics of TR115

    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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Tarapeutics Science Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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