肿瘤细胞治疗研究
英文原题：TR115 VS Investigator's Choice in Relapsed/Refractory Peripheral T/NK Cell Lymphoma
这是一项 III 期注册临床试验，评估细胞治疗用于外周 T 细胞淋巴瘤、淋巴瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 180 例。试验地点：中国 · 北京（共 1 个中心，其中中国 1 个）。登记号：NCT07639879。
不限性别 · ≥ 18 Years
纳入标准： • 组织学确诊外周T细胞淋巴瘤（PTCL），包括PTCL非特指型、血管免疫母细胞性T细胞淋巴瘤（AITL）、间变性大细胞淋巴瘤（ALCL）或NK/T细胞淋巴瘤（NKTCL）。 • 至少接受过一线全身治疗，并既往使用过至少一种新型药物（如西达本胺、普拉曲沙、维布妥昔单抗等），或对上述治疗难治/不耐受。 • 年龄≥18岁。 • ECOG体能状态评分0至1。 • 至少有一个符合Lugano 2014标准的可测量病灶（淋巴结最长径≥1.5 cm，或结外病灶≥1.0 cm）。 • 器官功能足够：ANC≥1.5×10^9/L，血小板≥100×10^9/L，血红蛋白≥100 g/L，总胆红素≤正常值上限（ULN）的1.5倍，ALT/AST≤ULN的2.5倍（肝受累时≤5倍），肌酐清除率≥50 mL/min（Cockcroft-Gault公式），LVEF≥50%，QTcF男性<450 ms、女性<470 ms。 • 愿意提供存档或新鲜肿瘤组织。 • 预期生存期≥3个月。 排除标准： • 既往使用EZH2或EZH1/2抑制剂后疾病进展（不耐受者可考虑入组）。 • 已知淋巴瘤累及中枢神经系统。 • 存在需全身治疗的活动性未控制感染。 • 有临床意义或未控制的心血管疾病。 • 既往接受过异基因干细胞移植，或首次给药前90天内接受过自体干细胞移植。 • 妊娠或哺乳期，或不愿采取有效避孕措施。 • 过去5年内患有其他恶性肿瘤，充分治疗的基底细胞癌、鳞状细胞癌、原位癌或甲状腺癌除外。 • 计划接受米托蒽醌脂质体治疗且既往多柔比星累积剂量≥350 mg/m²（或等效蒽环类药物暴露）。
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)
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：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.
次要终点：Overall Survival (OS)；Objective Response Rate (ORR)；Disease Control Rate (DCR)；Duration of Response (DOR)；Time to Response (TTR)；Safety and Tolerability；Population Pharmacokinetics of TR115
这是一项随机、开放、多中心III期研究，评估EZH2抑制剂TR115与研究者选择方案（西达本胺、戈利度卡替尼、米托蒽醌脂质体或吉西他滨）治疗复发和/或难治性外周T/NK细胞淋巴瘤患者的疗效和安全性。约180例患者按1:1比例随机分组。主要终点为由独立审查委员会（IRC）评估的无进展生存期（PFS），关键次要终点为总生存期（OS）。研究将在中国约40至60个中心开展。
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.
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