Treatment of Metastatic Melanoma With Autologous Melan-A/MART-1 Specific CTL Clones
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of an adoptive immunotherapy specific for Melan-A/MART1 antigen in metastatic melanoma patients whose tumor express this antigen but also HLA-A2
研究概览
简要总结
Most of HLA-A2 melanomas express Melan-A/MART-1 antigen and are recognized by tumor reactive Melan-A specific T lymphocytes. By using blood samples from HLA-A2 melanoma patients (stage III and IV), our goal is to produce a tumor reactive Melan-A specific T cell clones and to conduct a phase I-II clinical trial, based on the infusion of several millions to several billions of these lymphocytes to the patient, in order to induce passive immunity against this antigen. Production of the clones will be performed in the Unit for Cellular and Gene Therapy from Nantes University Hospital. Therapeutic response, safety treatment but also localization and survival of infused T cell clones will be assessed. This approach is expected to precise the ability of the clones to migrate within the tumor and to transfer specific immunity.
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
- •HLA-A2 melanoma patients with :
- •either loco-regional or lymph node metastasis
- •transit nodules not surgically resectable
- •measurable cutaneous or visceral metastasis
- •Patients' tumor express Melan-A/MART-1 antigen.
- •No chemotherapy treatment (except for Deticene used before the first T cell clones infusion) or radiotherapy or immunotherapy in the last 4 weeks before infusion.
- •No other melanoma treatment during the protocol.
- •Life expectancy should be greater than 6 months.
- •General state with Karnowsky greater than 80, ECOG = 0, 1 or
- •Patient should be negative for HIV and B and C hepatitis.
- •Biological parameters at the beginning of the study: leucocytes ³ 2000 elements per mm3, hemoglobin ³ 10.5g/dl, platelets ³ 100 000 per mm3, phosphatases alcalines transaminases £ 1 time 1/2 compared to the normal.
- •Signed informed consent
排除标准
- •Cardio-vascular pathologies, evoluting and uncontrolled, (severe HTA), cardiac deficiency, severe angor, severe arrhythmia.
- •Infectious pathologies evoluting and requiring antibiotherapy.
- •Patients HIV+.
- •Transplanted patients or patients suffering from severe auto-immune disease.
- •Psychiatric troubles that do not allow the protocol follow-up.
- •Pregnant or breast-feeding women.
- •No contraception.
结局指标
主要结局
Evaluate the efficacy of an adoptive immunotherapy specific for Melan-A/MART1 antigen in metastatic melanoma patients whose tumor express this antigen but also HLA-A2
时间窗: one year
次要结局
- Evaluate whether infused T cell clones migrate to tumor sites. For this purpose, infused T cell clones will be characterized according to their Vß and Valpha using antibodies and/or PCR(after treatment)
- Evaluate whether infused T cell clones transfer a specific immunity.(J56 after treatment)
- evaluate infused Melan-A/MART1 reactive T cell clones tolerance(one year)