Local Treatment of Metastatic Melanoma With Autologous Lymphocytes and the Bispecific Antibody rM28
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- toxicity
研究概览
简要总结
Phase I/II clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic melanoma stage III/IV and unresectable metastasis.
详细描述
Phase I/II clinical trial to analyze safety and efficiency of intralesional application of the bispecific single chain antibody rM28 and autologous PBMCs in patients with metastatic melanoma stage III/IV and unresectable metastasis. The antibody is directed against epitops of human CD28 and the melanoma associated surface antigen HMV-MAA. Treatment over 5 days with dose escalation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •malignant melanoma stage III/IV
- •injectable soft tissue metastasis
- •informed consent given
- •Karnofsky >= 70%
排除标准
- •additional chemotherapeutical treatment
- •systemic glucocorticoids
- •brain metestasis
- •other malignancies
研究组 & 干预措施
Antibody
干预措施: rM28 (Drug)
Antibody
干预措施: autologous PBMCs (Drug)
结局指标
主要结局
toxicity
clinical response
次要结局
未报告次要终点
研究者
Thomas Eigentler
Study Coordinator
University Hospital Tuebingen