肿瘤细胞治疗研究
英文原题：Mesothelin/GPC3/GUCY2C-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 CAR-T 细胞治疗恶性肿瘤、实体瘤的安全性、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 1 个中心，其中中国 1 个）。登记号：NCT05779917。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： 1. 患有间皮素蛋白表达阳性的晚期癌症。 2. 预期生存期>12周。 3. 心、肺、肝、肾及血液功能充分。 4. 有可用的自体转导T细胞；流式细胞术检测的间皮素CAR表达率≥20%，且细胞毒性试验中对间皮素阳性靶细胞的杀伤率≥20%。 5. 已向患者/监护人解释知情同意内容，患者/监护人理解并签署知情同意书，并已获得知情同意书副本。 排除标准： 1. 既往接受过基因治疗。 2. 存在严重病毒感染，如HBV、HCV或HIV感染。 3. 已知HIV阳性。 4. 存在细菌、病毒、真菌等引起的活动性感染。 5. 研究者认为不适合参加研究的其他严重疾病。 6. 妊娠或哺乳期女性。 7. 接受全身性糖皮质激素治疗（泼尼松等效剂量≥0.5 mg/kg/日）。 8. 研究者认为不适合参加研究的其他情况。
Inclusion Criteria: 1\. Patients with advanced cancer that expresses Mesothelin protein; 2. Life expectancy \>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of Mesothelin-CAR determined by flow-cytometry and killing of Mesothelin-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 Mesothelin-CAR T cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5. · six months
次要终点：Percent of Patients with best response as either complete remission or partial remission.；Median CAR-T cell persistence
研究者已构建第二代间皮素靶向CAR-T细胞，该细胞可分泌IL-21与抗PD-1单链可变片段（scFv）的融合蛋白，并已通过多项体内外研究验证其抗肿瘤功能。拟开展临床研究，测试该CAR-T细胞用于间皮素表达阳性癌症患者免疫治疗的抗肿瘤作用。本I期研究将首次评估间皮素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 second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated.
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