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

NCT07639879 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: TR115-CN-PIII-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTCL; NK T-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Overall Survival (OS)

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

• Objective Response Rate (ORR)

  Up to 36 months

• Disease Control Rate (DCR)

  Up to 36 months

• Duration of Response (DOR)

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

• Time to Response (TTR)

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

Study Arms (2)

TR115 tablet

EXPERIMENTAL

Drug: TR115

Investigator's Choice

ACTIVE COMPARATOR

Drug: Investigator's Choice

Interventions

TR115 DRUG

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

TR115 tablet

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.

Investigator's Choice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tarapeutics Science Inc.: lead

Study Sites (1)

Peking University Cancer Hospital

Beijin, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yang Shu

CONTACT

86 13918983465; shuyang@tarapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 10, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 30, 2030
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

CN (1)