EUCTR2018-002752-33-NL进行中（未招募）1 期
A phase I/II trial towards the safety and efficacy of preemptive vaccination with PD-L silenced, minor histocompatibility antigen UTA2-1 peptide-loaded Dendritic Cells after Allogeneic Stem Cell Transplantation - mHag UTA2-1-loaded PD-L silenced DC vaccination after allo SCT
VU University Medical Center0 个研究点目标入组 12 人开始时间: 2018年8月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Patients with Multiple Myeloma (MM), or Chronic Lymphocytic Leukemia (CLL) or non hodgkin lymphoma (any grade) or acute myeloid leukemia AML
- •2. Recipient and donor have a mismatch in UTA2-1 mHag in the Graft versus Tumor (GvT) direction (recipient mHag positive, donor mHag negative).
- •4. Recipient and donor are positive for HLA-A*0201
- •5. Age 18-75 years
- •6. Absence of acute GvHD > grade 2 or extensive chronic GvHD
- •7. No treatment with immunosuppressive drugs such as prednisone, cyclosporine A and MMF at least 4 weeks prior to planned vaccination date.
- •8. WHO performance 0-2
- •9. Absence of severe cardiac hepatic, renal, or metabolic disease
- •10. Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. WHO performance 3-4
- •2. Presence of severe cardiac hepatic, renal, metabolic disease
- •3. Rapidly progressive disease,
- •4. Life expectancy < 3 months
研究者
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