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Starting soon Phase 3

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

NCT07639879 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2026-07-30
Last updated
2026-06-10

Condition(s) studied

PTCLNK T-Cell Lymphoma

Investigational drug(s) / intervention(s)

TR115 →Investigator's Choice

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Progression-Free Survival (PFS) — 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

Trial sites (1)

FacilityCityRegionStatus
Peking University Cancer Hospital Beijin Beijing Municipality

More Tarapeutics Science Inc. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07639879 on ClinicalTrials.gov ↗ ← All trials in China