TR115 VS Investigator's Choice in Relapsed/Refractory Peripheral T/NK Cell Lymphoma
2026年6月6日 更新者：Tarapeutics Science Inc.
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.
研究概览
研究类型
介入性
注册 (估计的)
180
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yang Shu
- 电话号码：86 13918983465
- 邮箱：shuyang@tarapeutics.com
学习地点
-
-
Beijing Municipality
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Beijin、Beijing Municipality、中国、100142
- Peking University Cancer Hospital
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接触：
- Yuqin Song
- 电话号码：86 10-88196118
- 邮箱：SongYQ_VIP@163.com
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：研究者的选择
|
Investigator's choice treatment with chidamide, golidocitinib, mitoxantrone hydrochloride liposome, or gemcitabine hydrochloride administered according to the respective approved prescribing information.
|
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实验性的：TR115 tablet
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TR115 will be administered orally twice daily until documented disease progression, unacceptable toxicity, withdrawal of consent, death, or study discontinuation.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-Free Survival (PFS)
大体时间：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
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From randomization to disease progression or death from any cause, whichever occurs first, assessed up to 36 months.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival (OS)
大体时间：From randomization to death from any cause, assessed up to 36 months.
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Time from randomization to death from any cause.
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From randomization to death from any cause, assessed up to 36 months.
|
|
Objective Response Rate (ORR)
大体时间：Up to 36 months
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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.
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Up to 36 months
|
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Disease Control Rate (DCR)
大体时间：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.
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Up to 36 months
|
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Duration of Response (DOR)
大体时间：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.
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From first documented response to disease progression or death, assessed up to 36 months.
|
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Time to Response (TTR)
大体时间：From randomization to first documented response, assessed up to 36 months.
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Time from randomization to first documented response (CR or PR) as assessed by IRC and investigator according to Lugano 2014 criteria.
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From randomization to first documented response, assessed up to 36 months.
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Safety and Tolerability
大体时间：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.
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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.
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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.
|
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Population Pharmacokinetics of TR115
大体时间：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.
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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.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月30日
初级完成 (估计的)
2029年7月30日
研究完成 (估计的)
2030年7月30日
研究注册日期
首次提交
2026年5月26日
首先提交符合 QC 标准的
2026年6月6日
首次发布 (实际的)
2026年6月10日
研究记录更新
最后更新发布 (实际的)
2026年6月10日
上次提交的符合 QC 标准的更新
2026年6月6日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.