Phase IB Clinical Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AloCELYVIR (Mesenchymal Allogenic Cells + ICOVIR-5) in Children, Adolescent and Young Adults With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) in Combination With Radiotherapy or Medulloblastoma in Relapse/Progression in Monotherapy
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Dose-Limiting Toxicities rate (DLTs)
研究概览
简要总结
The aim of this study is to assess the safety and efficacy of AloCELYVIR, which consist in bone marrow-derived allogenic mesenchymal stem cells infected with an oncolytic Adenovirus, ICOVIR-5. It has recently been proven that this type of cells are able of transporting oncolytic substances to tumor targets that are difficult to reach, such as medulloblastomas and gliomas, youth cancers located in the cranial cavity that have a poor prognosis and a fatal outcome. In addition, to exerting an anti-tumor action, this virus has the ability to stimulate the immune response, making the therapy even more effective. Thus, the diffuse intrinsic pontine glioma and the medulloblastoma in relapse/progression have been chosen to study the potential of this new advanced therapy through a weekly infusion for 8 weeks.
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
- 1 Year 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AloCELYVIR
Patients will received weekly infusion of AloCELYVIR during 8 weeks.
干预措施: AloCELYVIR (Biological)
结局指标
主要结局
Dose-Limiting Toxicities rate (DLTs)
时间窗: 1 Month
Proportion of patients who has experienced a DLT
次要结局
- Antiadenoviral tumoral immune response in patients(2,5 Months)
- Objective response rate(24 Months)
- Feasibility of the combination/monotherapy(1 Month)
- Progression-free survival (PFS)(24 Months)
- Incidence of treatment-Emergent Adverse Event(2,5 Months)
- Overall Survival (OS)(24 Months)
- Antiadenoviral humoral immune response in patients(2,5 Months)
- Replication kinetics of Icovir-5(2,5 Months)
研究者
Mrs. Laura Aranzasti
MD
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
