肿瘤细胞治疗研究
英文原题：GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR-T Cells Against Cancers
⚠ 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 Claudin18.2CAR-T 细胞治疗肺癌、恶性肿瘤、多发性骨髓瘤的安全性、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：NCT03198052。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准：患有表达GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR蛋白的晚期癌症；预期寿命>12周；心、肺、肝、肾功能充分；有可用的自体转导T细胞，流式细胞术显示上述相应CAR表达率≥20%，且细胞毒性试验中对表达相应靶抗原的靶细胞杀伤率≥20%；患者/监护人已获知并理解知情同意内容且签署同意书，并获知情同意书副本。排除标准：既往接受过基因治疗；严重病毒感染（如HBV、HCV、HIV等）；已知HIV阳性；活动性细菌、病毒、真菌等感染；研究者认为不适合参加的其他严重疾病；妊娠或哺乳；全身类固醇治疗（泼尼松等效剂量≥0.5 mg/kg/日）；研究者认为不适合的其他情况。
Inclusion Criteria: 1\. Patients with advanced cancer that expresses GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR protein; 2. Life expectancy \>12 weeks; 3. Adequate heart,lung,liver,kidney function; 4. Available autologous transduced T cells with greater than or equal to 20% expression ofGPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR-CAR determined by flow-cytometry and killing of GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR-positive targets greater than or equal to 20% in cytotoxicity assay; 5. 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. Severe virus infection such as HBV,HCV,HIV,et al; 3. Known HIV positivity; 4. Active infectious disease related to bacteria, virus,fungi,et al; 5. Other severe diseases that the investigators consider not appropriate; 6. Pregnant or lactating women; 7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day); 8. 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/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-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
患者将接受至少3个周期的CAR-T细胞治疗，可经全身或局部注射，剂量为1×10^6/kg至10×10^6/kg体重。
研究者分别构建了靶向GPC3、Mesothelin、Claudin18.2、GUCY2C、B7-H3、PSCA、PSMA、MUC1、TGFβ、HER2、Lewis-Y、AXL或EGFR的第三代CAR-T细胞，并通过多项体外和体内研究验证其抗癌功能。临床研究将评估这些CAR-T细胞单独或联合用于治疗表达相应靶抗原的人类癌症患者的抗癌作用。本I期研究将首次评估上述多靶点CAR-T细胞免疫治疗人类癌症的安全性、耐受性和初步疗效。
The third generation of CAR-T cells that target GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR have been constructed respectively and their anti-cancer function has been verified by multiple in vitro and in vivo studies.Clinical studies will be performed to test the anti-cancer function of the these individual or combination of the CAR-T cells for immunotherapy of human cancer patients with GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR -CAR-T cell immunotherapy on human cancers will firstly be tested.
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