肿瘤细胞治疗研究
英文原题：GPC3-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression
⚠ 该试验的登记信息已有 27 个月未更新， 页面上显示的「招募中」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 I 期注册临床试验，评估 CAR-T 细胞治疗肝细胞癌、多发性骨髓瘤、肺癌的安全性、可行性及初步疗效。当前状态：招募中。计划入组 30 例。试验地点：中国 · 广州（共 2 个中心，其中中国 2 个）。登记号：NCT03198546。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： 1. 患有 GPC3 蛋白表达阳性的晚期肝细胞癌（HCC）。 2. 预期生存期>12周。 3. Child-Pugh-Turcotte 评分<7。 4. 心、肺、肝、肾功能充分。 5. 有可用的自体转导 T 细胞；流式细胞术测得 GPC3 CAR 表达≥20%，且细胞毒性试验中对 GPC3 阳性靶细胞的杀伤率≥20%。 6. 患者/监护人已获解释并理解知情同意内容，签署同意书并取得副本。 排除标准： 1. 既往接受过基因治疗。 2. 肿瘤体积>25 cm。 3. 严重病毒感染，如 HBV、HCV、HIV 等；已知 HIV 阳性。 4. 有肝移植史。 5. 存在活动性细菌、病毒、真菌等感染。 6. 研究者认为不适合参加的其他严重疾病。 7. 妊娠或哺乳期女性。 8. 正在接受全身性类固醇治疗，剂量≥泼尼松等效剂量0.5 mg/kg/日。 9. 研究者认为不适合参加的其他情况。
Inclusion Criteria: 1. patients with advanced HCC,which express GPC3 protein. 2. Life expectancy \>12 weeks 3. Child-Pugh-Turcotte score \<7 4. Adequate heart,lung,liver,kidney function 5. Available autologous transduced T cells with greater than or equal to 20% expression of GPC3 CAR determined by flow-cytometry and killing of GPC3-positive targets greater than or equal to 20% in cytotoxicity assay 6. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. - Exclusion Criteria: 1. Had accepted gene therapy before; 2. Tumor size more than 25cm; 3. Severe virus infection such as HBV,HCV,HIV,et al 4. Known HIV positivity 5. History of liver transplantation 6. Active infectious disease related to bacteria, virus,fungi,et al 7. Other severe diseases that the investigators consider not appropriate; 8. Pregnant or lactating women 9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day) 10. Other conditions that the investigators consider not appropriate. -
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：Number of Patients with Dose Limiting Toxicity · A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GPC3-T2-CAR T cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5. · three months
次要终点：Percent of Patients with best response as either complete remission or partial remission.；Median CAR-T cell persistence
选择可能从靶向 GPC3 和 TGFβ 的 CAR-T 细胞治疗中获益的合适 HCC 患者进入 CAR-T 细胞治疗组。
研究者已构建靶向 GPC3 的第三/四代 CAR-T 细胞（GPC3-CAR-T）和/或靶向可溶性 TGFβ 的 CAR-T 细胞，并通过多项体内外研究验证其抗肝细胞癌功能。本 I 期研究将首次评估 GPC3/TGFβ 靶向 CAR-T 细胞治疗 GPC3 表达阳性肝细胞癌患者的安全性、耐受性和初步疗效。
The third/fourth generation of CAR-T cells that target GPC3 (GPC3-CART cell) and/or soluble TGFβ (GPC3/TGFβ-CART )have been constructed and their anti-HCC function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test the anti-cancer function by the GPC3/TGFβ-CAR-T cells in human HCC patients with GPC3 expression. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/TGFβ-CAR-T cell immunotherapy on human will firstly be tested.
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