肿瘤细胞治疗研究
英文原题：4SCAR19U T Cells Targeting B Cell Malignancies
这是一项 I 期注册临床试验，评估工程化 T 细胞治疗 B 细胞恶性肿瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 30 例。试验地点：中国 · 深圳（共 1 个中心，其中中国 1 个）。登记号：NCT05995015。
不限性别 · ≥ 6 Months 且 ≤ 75 Years
纳入标准： 1. 年龄大于6个月。 2. 原发B细胞恶性肿瘤表达CD19。 3. Karnofsky体能状态评分>80分，预期生存期超过1个月。 4. 血红蛋白>80 g/L。 5. 无采集血细胞的禁忌证。 排除标准： 1. 合并其他活动性疾病，导致治疗后反应难以评估。 2. 存在无法控制的细菌、真菌或病毒感染。 3. HIV感染。 4. 活动性HBV或HCV感染。 5. 妊娠或哺乳期。 6. 治疗前一周内接受全身性类固醇治疗。 7. 既往CAR-T治疗失败。
Inclusion Criteria: 1. Age older than 6 months. 2. Primary B cell surface expression of CD19. 3. The KPS score over 80 points, and survival time is more than 1 month. 4. Greater than Hgb 80 g/L. 5. No contraindications to blood cell collection. Exclusion Criteria: 1. Accompanied with other active diseases, and difficult to assess response after treatment. 2. Bacterial, fungal, or viral infection, unable to control. 3. Living with HIV. 4. Active HBV or HCV infection. 5. Pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. Prior failed CAR-T treatment.
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 4SCAR19U CAR-T cells infusion · Safety of 4SCAR19U T cells in patients with relapsed and refractory B-ALL, BCL using CTCAE 4 standard to evaluate the level of adverse events · 24 weeks
次要终点：Anti-tumor activity of 4SCAR19U cells after infusion
本研究旨在评估采用新型CD19特异性CAR-T产品4SCAR19U T细胞治疗CD19阳性血液系统恶性肿瘤的通用CAR-T细胞疗法的可行性、安全性和疗效，同时进一步了解4SCAR19U T细胞的功能及其在患者体内的持续情况。本研究为多中心I期试验。
The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling patients from multiple clinical centers.
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