Study of Anti-Mesothelin Car NK Cells in Epithelial Ovarian Cancer
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Allife Medical Science and Technology Co., Ltd.
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 29, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | November 2018 | ||
| 预计主要完成日期 | November 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Occurrence of treatment related adverse events as assessed by CTCAE v4.0[ Time Frame: Day 3-Year 2 after injection ] defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Study of Anti-Mesothelin Car NK Cells in Epithelial Ovarian Cancer | ||
| 正式标题 ICMJE | Clinical Study on the Safety and Efficacy of Anti-Mesothelin Car NK Cells With Epithelial Ovarian Cancer | ||
| 简要概况 | This is a single centre、single arm、open-label，to investigate the safety and efficacy of anti-Mesothelin Car NK Cells With Epithelial ovarian cancer |
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| 详细说明 | Ovarian cancer ranks second in gynecologic malignancies, but mortality ranks first. It is one of the most serious malignant tumors that threaten women's lives. It is urgent to explore new treatment methods, such as introduction. Tumor immunotherapy strategies to improve treatment outcomes and patient quality of life. Car is a group of fusion proteins composed of multiple parts, including antigen recognition region, transmembrane region, and NK cell stimulation region. NK cells are naive immune cells that are not restricted by MHI and can be activated without additional co-stimulatory regions. After activation, granulin-B and γ-interferon are released, thereby inducing apoptosis of tumor cells and lysis of tumor cells. The study will follow a 3 + 3 design of dose- escalating cohorts. After a patient enrolls,leukapheresis will be performed to obtain peripheral blood mononuclearcells which will be sent to a manufacturing site to produce anti-Mesothelin Car NK cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient Treated patients will undergo serial measurements of safety, to lerability and response. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Early Phase 1 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
30 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 2021 | ||
| 预计主要完成日期 | November 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Mesothelin-positive patients with stage II-IV epithelial ovarian cancer.（Mesothelin expression ≥50% of tumor cells）（Patients with recurrence are not excluded） 2. Male or female, 18 to 70 years old (including 18 and 70 years old) 3. The excepted survival ≥ 6 months,Karnofsky activity function status score ≥ 60 points 4. there are measurable lesions according to the RECIST 1.1 standard. 5. Bone marrow function (blood routine) satisfies: the number of neutrophils > 1×109/L platelet > 7.5×109/L; hemoglobin > 90 g/L; total bilirubin < 2.0 mg/dL; creatinine < 1.5 times the upper limit; albumin < 2 g/L; ALT or AST < 5 times the upper limit; creatinine clearance rateby Cockcroft-Gault formula< 40 mL/min 6. Coagulation parameters: INR ≤ 1.5, PTT < 1.2 times the upper limt 7. Patients did not receive any chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs PD-1, PDL-1) or other anticancer treatment 2-4 weeks before admission, and the treatment-related toxicity reaction ≤1 level prior to enrollment（except low toxicity lose hair for example） 8. Venous channel is unobstructed, which can meet the needs of intravenous drip 9. HIV test was negative; HBV and HCV were negative 10. Voluntary informed consent is given, agree to follow the trial treatment and visit plan Exclusion Criteria: 1. Patients with hypertension (> 160/95 mmHg) are uncontrollable; coronary heart disease and angina pectoris are unstable (Canadian Cardiovascular Association Level II and above), or recurrent within 6 months 2. Patients suffer from concurrent or central nervous system diseases 3. Patients with severe autoimmune diseases or immunodeficiency diseases 4. Patient's lung function has the following abnormalities: FEV (forced expiratory volume), < 30%; DLCO (diffusing capacity of lung for carbon monoxide) < 30%; oxygen saturation < 90% 5. Patients treated with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets) 6. Patients with Severe liver and kidney dysfunction 7. Patients with Severe bacterial and viral infections 8. Patients are pregnant or nursing 9. Patients used corticosteroids within 4 weeks prior to enrollment(except patients with inhaled hormone) 10. Patients participated in other clinical trials within 30 days. 11. Patients had other conditions that were not appropriate for the group determined by the researchers. | ||
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| 年龄 | 最小年龄：18 Years ，最大年龄：70 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Allife Medical Science and Technology Co., Ltd. | ||
| 合作者 ICMJE | |||
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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