PTCLPhase 3NCT07639879
TR115 VS Investigator's Choice in Relapsed/Refractory Peripheral T/NK Cell Lymphoma
A Phase 3 study testing TR115 and Investigator's Choice in people with PTCL and NK T-Cell Lymphoma, run by Tarapeutics Science Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTCL, NK T-Cell Lymphoma
- What is being tested?
- TR115 and Investigator's Choice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 30 Jul 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Cancer Hospital
Beijin, Beijing Municipality, 100142
Yuqin Song, 86 10-88196118, SongYQ_VIP@163.com
About this study
Official 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
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
- Being tested
- TR115, Investigator's Choice
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR115Drug
TR115 will be administered orally twice daily until documented disease progression, unacceptable toxicity, withdrawal of consent, death, or study discontinuation.
Investigator's ChoiceDrug
Investigator's choice treatment with chidamide, golidocitinib, mitoxantrone hydrochloride liposome, or gemcitabine hydrochloride administered according to the respective approved prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| TR115 tablet | Experimental | Not described Receives: Drug: TR115 |
| Investigator's Choice | Active comparator | Not described Receives: Drug: Investigator's Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Assessed by Independent Review Committee (IRC) per Lugano 2014 criteria
Measured: From randomization to disease progression or death from any cause, whichever occurs first, assessed up to 36 months.
Secondary outcomes (7)
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jul 2029 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTCLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarapeutics Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639879
- Sponsor's protocol ID
- TR115-CN-PIII-01
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07639879
- Acronym / sponsor ID
- TR115-CN-PIII-01
- Conditions
- PTCL, NK T-Cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tarapeutics Science Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TR115 tablet | Experimental | Drug: TR115 |
| Investigator's Choice | Active comparator | Drug: Investigator's Choice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TR115TR115 will be administered orally twice daily until documented disease progression, unacceptable toxicity, withdrawal of consent, death, or study discontinuation. | Drug | TR115 tablet |
| Investigator's ChoiceInvestigator's choice treatment with chidamide, golidocitinib, mitoxantrone hydrochloride liposome, or gemcitabine hydrochloride administered according to the respective approved prescribing information. | Drug | Investigator's Choice |
Primary outcome
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
7 secondary outcomes
Overall Survival (OS)
Time frame: From randomization to death from any cause, assessed up to 36 months.
Objective Response Rate (ORR)
Time frame: Up to 36 months
Disease Control Rate (DCR)
Time frame: Up to 36 months
Duration of Response (DOR)
Time frame: From first documented response to disease progression or death, assessed up to 36 months.
Time to Response (TTR)
Time frame: From randomization to first documented response, assessed up to 36 months.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TR115 and Investigator's Choice in people with PTCL and NK T-Cell Lymphoma, run by Tarapeutics Science Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Shu (86 13918983465, shuyang@tarapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From randomization to disease progression or death from any cause, whichever occurs first, assessed up to 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.