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

Tarapeutics Science

Status and phase

Not yet enrolling

Phase 3

Conditions

PTCL

NK T-Cell Lymphoma

Treatments

Drug: Investigator's Choice

Drug: TR115

Study type

Interventional

Funder types

Industry

Identifiers

NCT07639879

TR115-CN-PIII-01

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)