NCT01823718Unknown1 期
Cell Bank of Epstein Barr Virus Specific Cytotoxic T Lymphocytes
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 18
- 试验地点
- 7
- 主要终点
- The safety of one to three injections of allogenic EBV specific CTLs will be determined through adverse event measurement
研究概览
简要总结
Patients patients enrolled in this study have a Lymphoma caused by EBV (after bone marrow transplantation, organ transplantation or patient immunodeficient.
They will receive one to three injections of allogenic CTL specific EBV.
The purpose of this study is to ensure that these injections can not cause a GVH and to study what the side effects are and to see whether this therapy might help patients with Lymphoma.
Immunological monitoring will also be studied.
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
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, without immunosuppressed organ transplant or immunocompromised and who received a kidney transplant, or kidney-pancreas, or heart or lung or heart-lung, or liver, or cells hematopoietic stem cells, and has given its consent
- •Aged 18 to 75 years Children aged more than 12 months,
- •Viral load determined EBV
- •Life expectancy> 1 month
- •Patient typed for HLA DP DQ DR ABC
- •Patients with lymphoma in the immunosuppressed associated with EBV and failure, partial response (<50%) or relapsed after treatment with monoclonal antibodies and / or chemotherapy completed for at least three weeks. Patients with partial response may have a PET scan to confirm the lack of response.
- •Patient with a measurable mass to assess the response or bone marrow infiltration and / or measurable blood and having frozen tumor material or having a repeat biopsy.
- •Availability of a CTL matching at least two HLA or one HLA after validation experts with tumor cells
- •test de cytotoxicity negative
排除标准
- •Patient Pregnant or lactating
- •Concurrent infection with HIV
- •EBV negative lymphomas
- •If acute GVHD> grade II J-1 before injection (case grafts CSH)
- •Treatment of molecules in pre-marketing authorization older than 21 days
- •No matching at least two CTL HLA or non expert validation for the use of CTL with HLA sharing a single tumor
- •Test of cytotoxicity positive
- •Lack of recognition of tumor cells when available
结局指标
主要结局
The safety of one to three injections of allogenic EBV specific CTLs will be determined through adverse event measurement
时间窗: 3 months post last injection
次要结局
- To determine the survival, and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines.(1 year)
研究者
研究点 (7)
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