Safety and Toxicity of Escalating Doses of Adoptively Infused ex Vivo Selected CD56+CD3- NK Cells on Day 7 Following Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Safety and toxicity donor CD56+CD3- NK cells
研究概览
简要总结
The investigators propose a nonrandomized, Phase I study to assess the safety of infusion of NK cells that will be selected from sibling donors and infused to patients with hematological malignancies early following allogeneic stem cell transplantation.
详细描述
Allogeneic hematopoietic stem cell transplantation (HSCT) is a very effective treatment for a number of hematological malignancies but relapse remains a major problem, especially in patients with high risk disease. Natural killer (NK) cells are immune cells that recognize and kill virally infected cells and tumor cells. NK cells are identified by the expression of the CD56 surface antigen and the lack of CD3. Their ability to kill tumor cells makes them promising to evaluate as effector cells for immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing an allogeneic HSCT from a sibling donor, as treatment for a hematological malignancy. The conditioning regimen, and in particular whether ablative or non ablative, will not be considered in the criteria for recruitment
- •Patient and donor Age >18 years
- •Patients and donors must have signed an informed consent form
- •The donor must be willing and capable of donating lymphocytes for NK selection using apheresis techniques
- •Donor must be fit to undergo leukapheresis
排除标准
- •Life expectancy < 3 months
- •ECOG performance status 3 or 4
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, life threatening cardiac arrhythmia
- •Patients will not be eligible if they receive in vivo T depletion with ATG, ALG or campath-1H
- •HIV-positive patients
- •Psychiatric illness/social situations that would limit compliance with study requirements and ability to comprehend the investigational nature of the study and provide informed consent
结局指标
主要结局
Safety and toxicity donor CD56+CD3- NK cells
时间窗: Day 28 post NK cell infusion
To evaluate the safety and toxicity of escalating doses of ex vivo selected donor CD56+CD3- NK cells, adoptively infused on day 7 following sibling allogeneic stem cell transplantation in patients with hematological malignancies. We will specifically look for the proportion of patients who develop infusion related toxicity. Toxicity will be defined as per the Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
次要结局
- Donor neutrophil and platelet engraftment(Day 28 post stem cell infusion)
- Rates of acute GVHD (grade 2-4)(Day 100 post stem cell infusion)
- Relapse rate(1 year post stem cell infusion)