肿瘤细胞治疗研究
英文原题：Universal 4SCAR7U Targeting CD7-positive Malignancies
这是一项 I 期注册临床试验，评估工程化 T 细胞治疗急性淋巴细胞白血病、淋巴瘤、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 30 例。试验地点：中国 · 深圳（共 1 个中心，其中中国 1 个）。登记号：NCT05995028。
不限性别 · ≥ 6 Months 且 ≤ 75 Years
纳入标准： 1. 年龄大于6个月。 2. 通过免疫组化染色或流式细胞术证实癌细胞表达CD7及其他表面抗原。 3. Karnofsky体能状态评分>80分，预期生存期>3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感染或丙型肝炎病毒（HCV）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无法遵守研究要求。
Inclusion Criteria: 1. Age older than 6 months. 2. Confirmed expression of CD7 and additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry. 3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 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 C virus (HCV) infection. 4. Pregnant or nursing women may not participate. 5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial. 6. Previous treatment with any gene therapy products. 7. Patients, in the opinion of investigators, may not be 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：Safety of infusion · Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria. · 6 months
次要终点：Clinical response
本临床试验旨在评估基于4SCAR7U设计的通用型CAR-T细胞，使用CD7特异性通用CAR-T治疗CD7阳性血液系统恶性肿瘤的可行性、安全性和疗效。研究还将进一步了解靶向CD7的CAR-T细胞在血液系统恶性肿瘤患者中的功能及持续情况。
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T cells based on 4SCAR7U design against CD7-positive hematological malignancies using CD7 specific universal CAR T cells. The study also aims to learn more about the function of CD7 targeting CAR T cells and their persistence in patients of hematological malignancies.
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