肿瘤细胞治疗研究
英文原题：CAR-NK Cells (CL-NK-003) in Pancreatic Cancer
这是一项 I 期注册临床试验，评估细胞治疗用于胰腺癌的安全性、可行性及初步疗效。当前状态：招募中。计划入组 9 例。试验地点：中国 · 上海（共 1 个中心，其中中国 1 个）。登记号：NCT07425483。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： 1. 年龄18至75岁。 2. 局部晚期、转移性或复发性胰腺癌；免疫组化检测eGR1阳性（膜阳性肿瘤细胞比例>40%，表达强度≥2+）；标准治疗失败、不耐受或拒绝标准治疗。 3. 至少有一个符合RECIST 1.1标准的可测量病灶。 4. 至少4周未接受抗肿瘤治疗。 5. ECOG体能状态评分0至2。 6. 预期生存期超过12周。 7. 血液学指标：中性粒细胞≥1.5×10^9/L、淋巴细胞≥0.8×10^9/L、血红蛋白≥100 g/L、血小板≥75×10^9/L。 8. 血生化：总胆红素≤正常值上限（ULN）的2倍，ALT≤ULN的3倍，AST≤ULN的3倍，肌酐清除率≥正常值下限（LLN）（Cockcroft-Gault公式）。 9. 自愿参加本临床研究并愿意签署书面知情同意书。 排除标准： 1. 中枢神经系统受累证据。 2. 既往接受过过继细胞治疗。 3. 存在未控制的活动性感染，包括但不限于HBV、HCV、HIV或梅毒螺旋体血清学阳性。 4. 3个月内接种过减毒活疫苗。 5. 有免疫缺陷病史。 6. 存在活动性自身免疫性疾病。 7. 筛查前2周内定期使用全身性皮质类固醇，且任一天泼尼松剂量>10 mg/日（或等效剂量）。 8. 存在严重疾病，包括但不限于：严重呼吸系统疾病；严重心血管疾病（既往接受冠状动脉旁路移植术/CABG或经皮冠状动脉介入治疗/PCI；过去6个月内心肌梗死/不稳定型心绞痛、NYHA III至IV级充血性心力衰竭、LVEF<50%或难治性高血压；QTc间期>480 ms、长QT或短QT综合征；既往有室性心律失常或正在使用抗心律失常药物/植入心律转复除颤器/ICD治疗室性心律失常）；控制不佳的糖尿病或其他代谢性疾病；严重胃肠道疾病（严重消化道出血、CTCAE≥2级严重腹泻或需干预的严重胃肠梗阻）。 9. 对研究药物或其成分可能发生严重不良事件、过敏反应或其他禁忌证。 10. 妊娠或哺乳期女性。 11. 有神经或精神疾病史。 12. 研究者判定不适合参加本临床研究。
Inclusion Criteria: * 1\. Aged 18-75 years;2. Locally advanced, metastatic, or recurrent pancreatic cancer, with immunohistochemical detection of eGR1 (membrane positive tumor cell rate \>40% and expression intensity ≥2+), who have failed, been intolerant to or reject standard treatment;3. At least 1 measurable lesion according to RECIST 1.1;4. Have not received anti-tumor treatment for at least 4 weeks;5. ECOG performance status of 0-2;6. Estimated life expectancy more than 12 weeks;7. Hematology: neutrophils ≥ 1.5×10\^9/L, lymphocytes ≥ 0.8×10\^9/L, hemoglobin ≥ 100 g/L, and platelets ≥ 75 × 10\^9/L;8. Blood biochemistry: total bilirubin ≤ 2×ULN, alanine aminotransferase ≤ 3×ULN, aspartate aminotransferase ≤ 3×ULN, and creatinine clearance ≥ LLN (Cockcroft-Gault formula);9. Volunteer to participate in this clinical study and willing to sign written informed consent. Exclusion Criteria: * 1\. Evidence of central nervous system involvement;2. Have received adoptive cell therapy;3. Patients with any uncontrolled active infection, including but not limited to: HBV, HCV, HIV, or treponema pallidum serology positive;4. Vaccinated with a live attenuated vaccine within 3 months;5. History of immunodeficiency;6. Active autoimmune disease;7. Regular use of systemic corticosteroids within 2 weeks prior to screening at a dose exceeding prednisone 10 mg/day (or equivalent) on any day; 8. Have severe conditions, including but not limited to: (1) severe respiratory diseases; (2) severe cardiovascular diseases (previous history of CABG/PCI; myocardial infarction/unstable angina pectoris, congestive heart failure of NYHA III-IV, left ventricular ejection fraction \< 50%, or poorly controlled hypertension within 6 months; QTc interval \> 480ms, long or short QT syndrome; previous history of ventrical arrhythmia, or ventrical arrhythmia under anti-arrhythmic drugs/ICD); (3) poorly controlled diabetes and other metabolic diseases; (4) severe gastrointestinal diseases (severe gastrointestinal bleeding, severe diarrhea of CTCAE ≥ 2, or severe gastrointestinal obstruction needing intervention);9. Possible severe adverse events, allergy or other contraindications to drugs or its component under study;10. Pregnant or lactating women;11. History of neurological or psychological disorders;12. Not suitable to participate this clinical study judged by the investigator.
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：Dose-limiting toxicity (DLT) · Safety · 42 days of first infusion；Treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (TESAE) · Safety · 42 days of first infusion；Number of participants with abnormal clinical laboratory parameters reported as TEAE · Safety · 42 days of first infusion；Number of participants with abnormal vital signs reported as TEAE · Safety · 42 days of first infusion；Number of participants with change from baseline in QT/QTc interval in electrocardiogram · Safety · 42 days of first infusion
次要终点：Objective response rate (ORR)；Disease control rate (DCR)；Progression-free survival (PFS)；Overall survival (OS)；Patient-reported quality of life (QoL)；Patient-generated subjective global assessment (PG-SGA)
至少6名患者接受固定剂量。
这是一项单中心、开放标签、首次人体、固定剂量研究，纳入胰腺癌患者。
This is a single-center, open-label, first-in-human, fixed-dose study in patients with pancreatic cancer.
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