跳至主要内容
临床试验/EUCTR2011-002941-36-NL
EUCTR2011-002941-36-NL进行中(未招募)不适用

Multicenter phase 1/2a study using T-cell receptor gene therapy in metastatic melanoma - TCR trial

KI-AV0 个研究点目标入组 25 人开始时间: 2012年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
25

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients must be = 18 years of age.
  • Patients must have measurable metastatic melanoma
  • Patients must be HLA-A2 positive.
  • Patients must have a clinical performance status of ECOG 0 or 1.
  • Patients of both genders must be willing to practice a highly effective method of birth control during treatment and for four months after receiving the preparative regimen.
  • Patients must be able to understand and sign the Informed Consent document.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 22
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 3

排除标准

  • Life expectancy of less than three months.
  • Patients with metastatic ocular or mucosal melanoma.
  • Requirement for systemic steroid therapy.
  • Patients who have a history of more than two CNS metastases.

研究者

发起方
KI-AV

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