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临床试验/NCT04477876
NCT04477876尚未招募不适用

Study of CD160, an Activating NK Cell Receptor, in Melanoma: a Potential Therapeutic Target?

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 55 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
55
主要终点
Percentage of effector cells activation and degranulation (CD69 and CD107a staining )

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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

结局指标

主要结局

Percentage of effector cells activation and degranulation (CD69 and CD107a staining )

时间窗: at inclusion

Difference between cells incubated with the anti CD160-TM antibody and with isotipic control ab ( flow cytometry)

次要结局

  • Overall survival(at 5 years post inclusion)
  • Phenotypic characteristics of NK cells(at inclusion)
  • Progression free survival(at 5 years)
  • Objective response rate(at 5 years)
  • cytokine profile(at inclusion)
  • Détection and quantification of sCD160 in patients' serum(at inclusion)

研究者

申办方类型
Other
责任方
Sponsor

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