NCT00611637终止1 期
A Pilot Clinical Trial of CMV pp65 Specific T Cell Adoptive Immunotherapy in Patients Who Have Undergone Allogeneic Stem Cell Transplantation for Malignant Disease
H. Kim Lyerly2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2005年8月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Number of CMV pp65 specific CD8+ T cells produced.
研究概览
简要总结
The purpose of this study is to determine the safety and feasibility of CMV specific, T cell adoptive immunotherapy in patients who have undergone allogeneic stem cell transplantation for malignant disease.
详细描述
The primary purpose of this clinical trial is to evaluate the safety of this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stratum 1: Subjects must be undergoing a non-myeloablative stem cell transplant from a 6/6 matched, sibling donor for the treatment of a malignancy
- •Stratum 2: Subjects must be undergoing a non-myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
- •Stratum 3: Subjects must be undergoing a myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
- •Donor must be CMV sero-positive.
- •Karnofsky performance status ≥ 70%.
- •Subject and donor must be one of the following HLA types: HLA A*0201, HLA-A*0101, HLA-A*2402, HLA-B*0702, HLA-B*0801, HLA-B*35, HLA-DR*1, or HLA-DR*
- •Availability of the stem cell donor to provide multiple PBMC samples for T-cell culture if needed. These samples could be obtained via a 90cc peripheral blood draw or through leukapheresis. Stem cell donor must satisfy BMT Program criteria for undergoing leukapheresis to provide DLI and consent to provide repeat leukapheresis if this is necessary.
- •Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
- •Ability to return to Duke University Medical Center for adequate follow-up as required by this protocol.
- •In order to receive their T cell infusions, subjects should be:
- •At least 2 weeks from the time of their allogeneic stem cell transplant.
- •Without Grade 3 or 4, non-hematologic, major organ toxicity within the preceding 1 week; all non major organ toxicities must have resolved to grade-2 or less.
排除标准
- •Pregnant women and nursing mothers.
- •Current or prior history of brain metastases.
- •More than 12 months since their allogeneic stem cell re-infusion.
- •HIV+, Hepatitis BsAg+, Hepatitis C Ab+
结局指标
主要结局
Number of CMV pp65 specific CD8+ T cells produced.
时间窗: Pre-infusion.
Development of grade III-IV GVHD or major organ toxicity.
时间窗: Continuously for 100 days post-transplant.
次要结局
- Presence of CMV in peripheral blood.(Tested before and following transplant and infusion.)
- Percentage of CD8+ T cells that are CMV pp65 specific.(Assessed weekly up to 6 months following T cell infusion.)
研究者
H. Kim Lyerly
Professor, Gen & Thor Surgery
Duke University
研究点 (2)
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