肿瘤细胞治疗研究
英文原题：Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors
这是一项 I/II 期注册临床试验，评估细胞治疗用于晚期实体瘤、实体瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 60 例。试验地点：中国 · 深圳（共 1 个中心，其中中国 1 个）。登记号：NCT07589530。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： • 签署知情同意书时年龄18至75岁。 • 组织学或细胞学确诊晚期或转移性实体瘤，并有记录证实TROP2表达（依据本地检测或中心确认）。 • 可用标准治疗后疾病进展、对标准治疗不耐受，或不适合接受标准治疗。 • 至少有一个符合RECIST 1.1标准的可测量病灶。 • ECOG体能状态0至1。 • 血液学、肾脏和肝脏功能足够，符合方案规定范围。 • 预期生存期≥12周。 • 有生育能力者愿意在研究期间及末次输注后方案规定期间内采取有效避孕措施。 • 能理解并愿意签署书面知情同意书。 排除标准： • 活动性中枢神经系统（CNS）转移或软脑膜疾病（经治疗且临床稳定≥4周者除外）。 • 既往接受过异基因造血干细胞移植或实体器官移植。 • 未控制的活动性感染，包括未控制的乙型肝炎、丙型肝炎或HIV感染。 • 需要全身免疫抑制治疗的活动性自身免疫性疾病。 • 有临床意义的心血管疾病（如过去6个月内心肌梗死或卒中、未控制的心律失常）。 • 淋巴细胞清除化疗前2周内（或5个半衰期内，以较长者为准）接受其他试验药物。 • 入组前3个月内接受过基因修饰细胞治疗。 • 淋巴细胞清除前7天内接受全身性糖皮质激素治疗，剂量>10 mg/日泼尼松等效剂量（生理替代治疗除外）。 • 妊娠或哺乳期。
Inclusion Criteria: * Age 18 to 75 years at the time of informed consent. * Histologically or cytologically confirmed advanced or metastatic solid tumor with documented TROP2 expression (per local testing or central confirmation). * Disease progression on, intolerance to, or ineligibility for available standard therapy. * At least one measurable lesion per RECIST 1.1. * ECOG performance status 0 to 1. * Adequate organ function (hematologic, renal, hepatic) within protocol-defined limits. * Life expectancy ≥ 12 weeks. * Willingness to use effective contraception during study participation and for a protocol-defined period after last infusion (if of childbearing potential). * Ability to understand and willingness to sign written informed consent. Exclusion Criteria: * Active central nervous system (CNS) metastases or leptomeningeal disease (unless treated and clinically stable for ≥ 4 weeks). * Prior allogeneic hematopoietic stem cell transplant or solid organ transplant. * Uncontrolled active infection, including uncontrolled hepatitis B, hepatitis C, or HIV infection. * Active autoimmune disease requiring systemic immunosuppression. * Clinically significant cardiovascular disease (e.g., recent myocardial infarction or stroke within 6 months, uncontrolled arrhythmia). * Receipt of another investigational agent within 2 weeks (or 5 half-lives, whichever is longer) prior to lymphodepleting chemotherapy. * Prior gene-modified cellular therapy within 3 months prior to enrollment. * Systemic corticosteroid therapy \> 10 mg/day prednisone equivalent within 7 days prior to lymphodepletion (excluding physiologic replacement). * Pregnant or breastfeeding.
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：Incidence of dose-limiting toxicities (DLTs) (CTCAE v5.0) · 28 days；Incidence and severity of treatment-emergent adverse events (AEs) · 12 months；Recommended Phase 2 dose (RP2D) of EB-NK-301 · 6 months
次要终点：Objective response rate (ORR) per RECIST 1.1；Duration of response (DoR)；Overall survival (OS)
在淋巴细胞清除化疗后依次递增EB-NK-301剂量，以评估安全性和DLT并确定RP2D。
在确定的RP2D下设立特定TROP2表达肿瘤类型的扩展队列，进一步评估安全性和初步疗效。
本研究评估试验性现货型异基因CAR-NK细胞产品EB-NK-301，该产品靶向TROP2，用于标准治疗后进展的晚期或转移性TROP2表达实体瘤成人患者。主要目标是评估安全性和耐受性、确定剂量限制性毒性（DLT）并确定II期推荐剂量（RP2D）。次要目标包括初步抗肿瘤活性、输注CAR-NK细胞的持续性及探索性免疫生物标志物。
study evaluates EB-NK-301, an investigational off-the-shelf allogeneic CAR-NK cell product targeting TROP2, in adults with advanced or metastatic solid tumors that express TROP2 and have progressed after standard therapy. The primary goals are to assess safety and tolerability, identify dose-limiting toxicities (DLTs), and determine a recommended Phase 2 dose (RP2D). Secondary goals include preliminary anti-tumor activity, persistence of infused CAR-NK cells, and exploratory immune biomarkers.
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