肿瘤细胞治疗研究
英文原题：Study of CD160, an Activating NK Cell Receptor, in Melanoma: a Potential Therapeutic Target?
⚠ 该试验的登记信息已有 75 个月未更新， 页面上显示的「尚未开始招募」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。
这是一项分期未标注的注册临床试验，评估细胞治疗用于黑色素瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 55 例。登记号：NCT04477876。
不限性别 · ≥ 18 Years · 接受健康志愿者
纳入标准：年龄≥18岁；ECOG评分0-2分；不可手术的III期或IV期黑色素瘤；尚未治疗或经一线或多线治疗后进展；书面同意参加本研究并纳入MelBase队列；有医疗保险。第二部分附加纳入标准：存在皮肤或皮下黑色素瘤病灶；同意皮肤活检，或在有淋巴结受累时按常规临床实践提供肿瘤样本，并签署知情同意。排除标准：妊娠或哺乳期女性；精神障碍；已参加其他临床试验；过去4周内接受化疗或放疗；合并其他实体瘤或血液肿瘤、慢性病毒感染（如HIV、HBV或HCV）；入组前4周内接受剂量超过10 mg的类固醇治疗；拒绝参加研究；受监护或辅助监护；享受国家医疗救助者。
Inclusion Criteria : * Patients aged18-years old or over * ECOG score between 0-2 * Inoperable stage III or stage IV melanoma * Naïve of treatment or in progression after one or several treatment lines * Give their written consent for the present study and be included in MelBase cohort. * health insurance coverage. Supplementary inclusion criteria for part II : * skin or subcutaneous melanoma lesions * agree and inform consent for a cutaneous biopsy or a tumor sample if presenting lymph nodes involvement if part of the usual clinical practice. Exclusion Criteria: * Pregnant and breastfeeding women * Patients with psychiatric disorders * Patients already included in another clinical trial * Having received chemotherapy or radiotherapy during the last 4 weeks, * Patient presenting another solid or blood cancer, chronic viral infection (e.g. HIV, HBV or HCV) * Been treated with more than 10mg of steroids until the 4 weeks before inclusion. * Refusal to participate to the study * Patients under guardianship or curatorship * Patients on state medical aid
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：Percentage of effector cells activation and degranulation (CD69 and CD107a staining ) · Difference between cells incubated with the anti CD160-TM antibody and with isotipic control ab ( flow cytometry) · at inclusion
次要终点：Overall survival；Overall survival；Overall survival；Overall survival；Overall survival；Progression free survival；Progression free survival；Progression free survival
过去10年，免疫治疗显著改善了黑色素瘤治疗结局，但仅40%-50%的患者对治疗有反应，约25%会产生获得性耐药。NK细胞可天然识别并杀伤肿瘤细胞，但肿瘤形成的免疫抑制微环境会降低其杀伤活性。CD160是研究团队发现并表征的一种NK细胞受体。CD160-GPI亚型受体结合可启动NK细胞细胞毒反应；NK细胞激活后会新合成跨膜亚型CD160-TM，进而放大已激活NK细胞的细胞毒作用。本研究拟评估晚期黑色素瘤患者NK细胞的表型（主要是CD160-TM表达或其诱导情况），并探讨使用抗CD160-TM激动抗体增强NK细胞依赖性肿瘤清除机制的治疗潜力。
Although immunotherapy revolutionized melanoma outcomes over the last 10 years, only 40-50% of patients respond to treatments and 25% develop acquired resistances. Natural Killer (NK) cells naturally recognize and kill tumor cells. However, the immunosuppressive micro-environment generated by the tumor decreases NK cells' killing activity. CD160 is a NK cell receptor identified and characterized in our laboratory. Engagement of the GPI isoform (CD160-GPI) initiates NK cell cytotoxic response. Upon NK cell activation, a transmembrane isoform (CD160-TM) is neo-synthesized which promotes the amplification of activated NK cell cytotoxicity. The aim of this study is to assess the phenotypic profile of advanced stages melanoma patients' NK cells (mainly CD160-TM expression or its induction) and therefore the therapeutic potential of the use of an anti-CD160-TM agonist antibody to boost the NK-dependent mechanism leading to tumor depletion.
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