NCT04802070已完成1 期
A Phase I Study of Adoptive Immunotherapy With Cytokine-Induced Killer Cells in Relapsed and Non-resectable Sarcomas After Multimodal Treatment.
Prof. Franca Fagioli1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年1月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
Monocentric, phase I study for advanced sarcoma with adoptive immunotherapy with Cytokine-Induced Killer (CIK).
In the first part of the study Patient's' peripheral blood will be collected and CIK cell expansion and storage will occur at the Regina Margherita Children's Hospital Cell Factory.
In the second part of the study the Maximum Tolerated Dose (MTD) will be determined in order to find the Recommended Dose for Phase II (RP2D)
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
- 10 Years 至 25 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
CIK
Experimental
干预措施: Autologous CIK (Drug)
结局指标
主要结局
DLT
时间窗: 6 weeks
Incidence of dose-limiting toxicity (DLT) associated with CIK autologous cells administration
次要结局
未报告次要终点
研究者
Prof. Franca Fagioli
Professor
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
研究点 (1)
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