EUCTR2016-000297-38-GB进行中（未招募）1 期
ong-term follow-up study of patients who have previously been exposed to UCART19 / ALLO-501 (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: 2016年4月15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
- 性别
- All
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
相似试验
进行中（未招募）
1 期
A study to evaluate the long-term safety of patients with advanced lymphoid malignancies who have been previously administered with UCART19Advanced lymphoid malignanciesMedDRA version: 20.0Level: LLTClassification code 10060390Term: Leukaemia lymphoblastic acuteSystem Organ Class: 100000004864EUCTR2016-000297-38-BEInstitut de Recherches Internationales Servier (I.R.I.S)200
进行中（未招募）
1 期
A study to evaluate the long-term safety of patients with advanced lymphoid malignancies who have been previously administered with UCART19Advanced lymphoid malignanciesMedDRA version: 20.0Level: LLTClassification code 10060390Term: Leukaemia lymphoblastic acuteSystem Organ Class: 100000004864EUCTR2016-000297-38-FRInstitut de Recherches Internationales Servier (I.R.I.S)200
进行中（未招募）
1 期
A study to evaluate the long-term safety of patients with advanced lymphoid malignancies who have been previously administered with UCART19Advanced lymphoid malignanciesMedDRA version: 20.0 Level: LLT Classification code 10060390 Term: Leukaemia lymphoblastic acute System Organ Class: 100000004864EUCTR2016-000297-38-ESInstitut de Recherches Internationales Servier (I.R.I.S)200
招募中
不适用
ong-term follow-up study of patients who have previouslybeen exposed to UCART19JPRN-jRCT2013190001clinical operation department International center for therapeutic research200
进行中（未招募）
1 期
ong-term follow-up of patients previously treated with autologous T cells genetically modified with viral vectors.CTIS2024-511684-28-00Autolus Limited111