NCT01822093已完成1 期
Phase I/II Study Investigating the Safety of ADV Specific T Cells in High-risk Paediatric Patients Post Allo-HSCT to Treat ADV Reactivation
Cell Medica Ltd3 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2012年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Number of subjects with new onset GVHD
研究概览
简要总结
Human Adenovirus-specific T-cells can persist and augment impaired adenovirus immune response post allogeneic haematopoietic stem cell transplant, and reduce the requirement for antiviral therapy without toxicity or increasing the occurrence of Graft Versus Host Disease. This is a Phase I/IIa open-label safety study, assessing the effects of administering adenovirus-specific T-cells (Cytovir ADV) to paediatric patients post haematopoietic stem cell transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 16 years or younger
- •Scheduled to undergo an allogeneic HSCT with an unrelated donor, mismatched unrelated donor, mismatched family donor or haplo identical donor
- •The subject (or legally acceptable representative) must give informed consent (and assent for subjects ≥ 12 years). All subjects will have a parent or guardian provide informed consent and the subject will provide witnessed verbal assent
- •Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG.
- •Meets requirements of Directive 2004/23/EC as amended and the UK statutory instruments pursuant therein
- •Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG
- •Passed medical assessment for stem cell donation
- •HdADV seropositive
- •Signed informed consent
- •Age 16 years or older
排除标准
- •Pregnant or lactating females
- •Co-existing medical problems that would place the patient at significant risk of death due to GVHD or its sequelae
- •Human Immunodeficiency Virus (HIV) infection
- •Pregnant or lactating females
- •(assessed prior to apheresis) Platelets < 50x109/L
研究组 & 干预措施
Cytovir-ADV
Experimental
Adenovirus-specific T-cells
干预措施: Cytovir-ADV (Biological)
结局指标
主要结局
Number of subjects with new onset GVHD
时间窗: 180 days
number of subjects developing NCI Grade 3-4 adverse events
时间窗: 180 days
次要结局
- Number of reported Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Suspected Expected Serious Adverse Reactions (SESARs)(180 days)
- Number of treatment days with other anti-infective drugs(180 days)
- Number of detectable HAdV-specific T-cells in vivo at each time point(180 days)
- Requirement for second infusion of HAdV-specific T-cells(180 days)
- Number of treatment days with antiviral drugs(180 days)
- Number of in-hospital days during 6 month post-infusion period(180 days)
研究者
研究点 (3)
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