Innovative Approaches for Targeted Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The purpose will be to evaluate safety using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.
研究概览
简要总结
Patients with resistant metastatic solid tumors failing all conventional modalities who are eligible for immunotherapy by bispecific antibodies.
First step: NST Second step: Patients with tumor cells expressing positive Her-2Neu and/or EpCAM with residual or recurrent disease following NST will be candidates for donor lymphocytes immunotherapy using bispecific antibodies.
Patients with no matched donor available, expressing positive Her-2Neu and/or EpCAM tumor cells, will be eligible for donor mismatched lymphocytes using in-vitro rIL-2 activated allogeneic lymphocytes targeted to the tumor by bispecific antibodies, Her-2Neu and/or EpCAM.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with metastatic solid tumors expressing Her-2/Neu or EpCAM, with available match donor for NST.
- •Patients with metastatic solid tumors not expected to be cured failing available conventional modalities, age >18, with no upper age limit.
- •Patients with metastatic breast cancer failing treatment with Herceptin.
- •Patients with metastatic cancer cells expressing Her-2/Neu or EpCAM.
- •Patients with evidence of disease following allogeneic stem cell transplantation with tumor cells expressing Her-2/Neu or EpCAM.
- •Karnofsky performance status >60%
- •Life expectancy > 3 months, to be able to assess response.
排除标准
- •Patients not fulfilling any of the above.
- •Patients with active or ongoing infection that may endanger their life, whenever immunosuppression may be counter-indicated.
- •Pregnant or lactating women.
- •Patients positive for HIV.
结局指标
主要结局
The purpose will be to evaluate safety using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.
次要结局
- To evaluate primary efficacy using donor lymphocytes labelled in-vitro with bispecific antibodies for metastatic cancer patients.