Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- To determine the feasibility of expanding allogeneic cytokine induced killer cells suitable for clinical application using a continuous perfusion culture system.
研究概览
简要总结
This is a phase 1 dose escalation study evaluating the use of activated T-cells to treat relapsed malignancy (cancer) following allogeneic hematopoietic cell transplantation, without causing GvHD.
详细描述
This study did not advance to dose expansion.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of recurrent or persistent hematologic malignancy following HLA matched allogeneic hematopoietic cell transplant
- •eligible for DLI
- •no evidence of GVHD
- •stable immunosuppressive regimen
- •adequate renal and liver function
排除标准
- •CML patients who have not received DLI, active infections
研究组 & 干预措施
Cytokine-induced Killer Cells
The first cohort =1X10 7 cf expanded cells/kg. The second cohort = 5x10 7 expanded cells/kg. The second cohort = 1X10 8 expanded cells/kg.
干预措施: Cytokine Induced Killer Cells (Drug)
结局指标
主要结局
To determine the feasibility of expanding allogeneic cytokine induced killer cells suitable for clinical application using a continuous perfusion culture system.
时间窗: 21 to 28days before infusion
To determine the infusional toxicity of ex vivo expanded allogeneic CIK cells in patients with recurrent or refractory disease following allogeneic hematopoietic cell transplantation.
时间窗: day of infusion up to 24 hours after infusion
To determine the incidence of Graft-versus-Host Disease (GVHD) following infusion of allogeneic CIK cells.
时间窗: first 100 days after infusion
To determine the maximum tolerated dose (MTD) of expanded CIK cells for infusion.
时间窗: day plus 100 after infusion
次要结局
- To assess donor-specific chimerism before and after treatment with allogeneic CIK cells.(3 months)
- To optimize the ex vivo expansion of CIK cells using a continuous perfusion culture system.(21-28 days)
- o determine the incidence of disease response following treatment with allogeneic CIK cells.(one year)
研究者
Robert Negrin
Professor of Medicine
Stanford University