肿瘤细胞治疗研究
英文原题：Clinical Study on the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies
Clinical Study on the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies
⚠ 该试验的登记信息已有 71 个月未更新， 页面上显示的「尚未开始招募」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项早期 I 期注册临床试验，评估 NK 细胞治疗血液系统恶性肿瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 36 例。试验地点：中国 · 杭州（共 1 个中心，其中中国 1 个）。登记号：NCT04662788。
不限性别 · ≥ 15 Years 且 ≤ 60 Years
纳入标准： 1. 根据美国国家综合癌症网络（NCCN）《急性髓系白血病临床实践指南》（2016年第1版），组织学确诊AML。 2. 复发或难治性AML（符合以下任一情况）： 1. 标准化疗后未达到完全缓解（CR）； 2. 首次诱导后达到CR，但CR持续时间<12个月； 3. 一次或多次挽救治疗后未能有效缓解； 4. 复发≥2次。 3. 骨髓原始细胞>5%（形态学）和/或>0.01%（流式细胞术）。 4. 总胆红素≤51 μmol/L，ALT和AST≤正常值上限的3倍，肌酐≤176.8 μmol/L。 5. 超声心动图显示左心室射血分数（LVEF）≥50%。 6. 肺部无活动性感染，室内空气下血氧饱和度≥92%。 7. 预期生存期≥3个月。 8. ECOG体能状态评分0至2。 9. 患者或其法定监护人自愿参加研究并签署知情同意书。 排除标准： 1. 有颅脑外伤、意识障碍、癫痫、脑血管缺血性或出血性疾病史。 2. QT间期延长或既往有严重心脏病，如严重心律失常。 3. 妊娠或哺乳期女性。 4. 存在严重活动性感染（单纯尿路感染和细菌性咽炎除外）。 5. 活动性乙型或丙型肝炎病毒感染。 6. 筛查前2周内接受全身类固醇治疗（近期或当前使用吸入性类固醇者除外）。 7. 既往接受过任何CAR-T细胞产品或其他基因修饰T细胞疗法。 8. 肌酐>2.5 mg/dL，或ALT/AST>正常值上限的3倍，或胆红素>2.0 mg/dL。 9. 存在其他不适合参加本试验的未控制疾病。 10. HIV感染。 11. 研究者认为可能增加患者风险或干扰研究结果的任何情况。
Inclusion Criteria: 1. Histologically confirmed diagnosis of AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1); 2. Relapsed or refractory AML (meeting one of the following conditions): 1. CR not achieved after standardized chemotherapy; 2. CR achieved following the first induction, but CR duration is less than 12 months; 3. Ineffectively after first or multiple remedial treatments; 4. 2 or more relapses; 3. The number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flowcytometry); 4. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L; 5. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 6. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%; 7. Estimated survival time ≥ 3 months; 8. ECOG performance status 0 to 2; 9. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent. Exclusion Criteria: 1. History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past; 3. Pregnant (or lactating) women; 4. Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis); 5. Active infection of hepatitis B virus or hepatitis C virus; 6. Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids; 7. Previously treated with any CAR-T cell product or other genetically- modified T cell therapies; 8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; 9. Other uncontrolled diseases that were not suitable for this trial; 10. Patients with HIV infection; 11. Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.
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) · Adverse events assessed according to NCI-CTCAE v5.0 criteria · Baseline up to 28 days after NK cells/Combined Monoclonal Antibodies infusion；Incidence of treatment-emergent adverse events (TEAEs) · Incidence of treatment-emergent adverse events \[Safety and Tolerability\] · Up to 2 years after NK cells/Combined Monoclonal Antibodies infusion
次要终点：Acute Myeloid Leukemia (AML), Overall response rate (ORR)；AML, Overall survival (OS)；AML, Event-free survival (EFS)；Quality of life；Activities of Daily Living (ADL) score；Instrumental Activities of Daily Living (IADL) score；Hospital Anxiety and Depression Scale (HADS) score
本临床研究评估NK细胞联合单克隆抗体治疗血液系统恶性肿瘤的安全性和有效性。
Clinical study on the safety and effectiveness of NK cells/combined monoclonal antibodies in the treatment of hematological malignancies
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