肿瘤细胞治疗研究
英文原题：Multi-CAR T Cell Therapy for Acute Myeloid Leukemia
这是一项 I/II 期注册临床试验，评估工程化 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 10 例。试验地点：中国 · 深圳（共 1 个中心，其中中国 1 个）。登记号：NCT03222674。
不限性别 · ≥ 2 Years 且 ≤ 75 Years
纳入标准： 1. 年龄大于2岁。 2. 通过免疫组化染色或流式细胞术可在恶性细胞中检出CD33、CD38、CD56、CD123、MUC1和CLL1表达。 3. Karnofsky体能状态评分>80分，预期生存期>2个月。 4. 骨髓、肝和肾功能满足以下实验室要求：心脏射血分数≥50%，氧饱和度≥90%，肌酐≤正常值上限的2.5倍，AST和ALT≤正常值上限的3倍，总胆红素≤2.0 mg/dL。 5. 血红蛋白≥80 g/L。 6. 无细胞分离禁忌证。 7. 能够理解并愿意签署书面知情同意书。 排除标准： 1. 严重疾病或医疗状况导致无法按方案管理，包括活动性、未控制的感染。 2. 存在未能通过适当治疗控制的活动性细菌、真菌或病毒感染。 3. 已知HIV或乙型肝炎病毒（HBV）感染。 4. 妊娠或哺乳期女性不得参加。 5. 入组前一周内接受全身性糖皮质激素治疗。 6. 既往接受过任何基因治疗产品。 7. 研究者认为患者可能不符合资格或无法遵守研究要求。
Inclusion Criteria: 1. Age older than 2 years. 2. CD33, CD38, CD56, CD123, MucI, and CLL1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry. 3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 2 months. 4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL. 5. Hgb≥80g/L. 6. No cell separation contraindications. 7. Abilities to understand and the willingness to provide written informed consent. Exclusion Criteria: 1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. 2. Active bacterial, fungal or viral infection not controlled by adequate treatment. 3. Known HIV or hepatitis B virus (HBV) infection. 4. Pregnant or nursing women may not participate. 5. History of glucocorticoid for systemic therapy within the week prior to entering the test. 6. Previously treatment with any gene therapy products. 7. Patients, in the opinion of investigators, may not be eligible or not able to comply with the 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：percentage of patients with treatment related adverse effect · percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical labs and so on. · a year
次要终点：Anti tumor activity of fourth generation CAR-T cells in patients with relapsed or refractory AML
CAR-T细胞治疗AML。
本临床试验旨在评估靶向不同AML细胞表面抗原的多靶点CAR-T细胞疗法用于复发或难治性急性髓系白血病（AML）患者的可行性、安全性和疗效。研究还将进一步了解多靶点CAR-T细胞在患者体内的功能和持续情况。
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multi-CAR T cell therapy targeting different AML surface antigens in patients with relapsed or refractory acute myeloid leukemia (AML). Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.
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