A Phase I/II Single Center Study to Assess the Safety, Tolerability and Feasibility of Pre-emptive Immunotherapy With in Vitro Expanded Natural Killer Cells in Patients Treated With Haplo-HSCT for AML/MDS
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse events including GvHD and infections.
研究概览
简要总结
The study examines the application of expanded natural killer cells (NK cells) following haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) for AML or MDS. Haplo-HSCT is a preferred treatment option for patients with AML or MDS without a HLA-matched donor. With administration of cyclophosphamide post-transplant , the safety of the procedure is similar to a HSCT from a HLA-identical donor. Relapse of AML/MDS represents a serious problem following haplo-HSCT. NK cells are immune cells able to destroy tumor cells. Their potency has been established particularly in the setting of a haplo-HSCT. In the current study, study participants undergoing haplo-HSCT will receive expanded NK cells from their respective stem-cell donors following haplo-HSCT. The primary goal of the study is to establish the safety and feasibility of this approach. In addition, the activity of the NK cells will be examined.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •No HLA-matched related or unrelated donor available
- •AML or MDS-EB with indication for a haplo-HSCT according to the guidelines of the University Hospital Basel Stem Cell Transplant Team
- •Judged by the transplant physicians to have adequate organ function and no contraindications to haplo-HSCT
- •Available related haploidentical donor
- •Written informed consent
- •>18 years old, haploidentical parent, sibling or other relative
- •Donor suitable for cell donation and apheresis according to standard criteria
- •Written informed consent
排除标准
- •APL diagnosis
- •Presence of relevant (mean fluorescence intensity >2000) donor-specific anti-HLA antibodies
- •Pregnancy
- •Necessity of immunosuppression apart from GvHD prophylaxis
- •Exclusion Criteria:
- •Pregnancy
结局指标
主要结局
Incidence and severity of adverse events including GvHD and infections.
时间窗: 1 year following haplo HSCT
As defined by the CTCAE version 4.03 and the NIH Scoring of GvHD.
次要结局
- Incidence of graft rejection(1 year following haplo HSCT)
- Number of NK cells given per kg body weight(30 days following haplo-HSCT)
- Progression-free survival (PFS)(1 year following haplo HSCT)
- Incidence of AML/MDS-EB complete morphological and molecular remission (CR) at day + 30, + 90, +180 and 1 year post allo-HSCT(1 year following haplo HSCT)
- Number of NK-DLI infusions applied(30 days following haplo-HSCT)