肿瘤细胞治疗研究
英文原题：IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory Acute Myeloid Leukemia
⚠ 该试验的登记信息已有 72 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 CAR-T 细胞治疗急性髓系白血病的安全性、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：NCT04599543。
不限性别
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CD123阳性AML。 2. 复发或难治性CD123阳性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： 有以下任一情况者不得参加本试验： 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 CD123+ AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1); 2. Relapsed or refractory CD123+ 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: Subjects with any of the following exclusion criteria were not eligible for this trial: 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 IL3 targeted CAR T-cells infusion；Incidence of treatment-emergent adverse events (TEAEs) · Incidence of treatment-emergent adverse events \[Safety and Tolerability\] · Up to 2 years after IL3 targeted CAR T-cells 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
本研究评估IL3 CAR-T细胞治疗CD123阳性复发和/或难治性急性髓系白血病患者。
A Study of IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory Acute Myeloid Leukemia.
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