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临床试验/EUCTR2016-000297-38-ES
EUCTR2016-000297-38-ES进行中(未招募)1 期

ong-term follow-up study of patients who have previously been exposed to UCART19 (allogeneic engineered T-cells expressing a lentiviral-based anti-CD19 chimeric antigen receptor)

Institut de Recherches Internationales Servier (I.R.I.S)0 个研究点目标入组 200 人开始时间: 2018年10月25日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
200

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

入选标准

  • - Written informed consent obtained prior any study-specific procedure (patient or parent(s) or legal representative);
  • - Patient dosed with UCART19 who completed or discontinued early from a sponsored or from any investigator-initiated study that tested UCART19, or patients who were administered UCART19 under a special access scheme (compassionate use);
  • - Female patients of childbearing potential and male patients with partners of childbearing potential must continue to use an effective method of birth control as well as their partners.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 100
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 75
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 25

排除标准

  • No exclusion criteria for this study

研究者

发起方
Institut de Recherches Internationales Servier (I.R.I.S)

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