T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 6
- 主要终点
- Safety as measured by local and systemic toxicities
研究概览
简要总结
This phase I trial is to investigate the safety and the possible side effects of bi-specific antibody armed T-cell therapy when given together with low-dose IL-2 in treating patients with Her2-positive neoplasms of digestive system. Expanded autologues T cells that have been coated with bi-specific antibodies, such as anti-CD3 and anti-human epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells from growing. Interleukin-2 may stimulate white blood cells to kill tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Perform a phase I clinical trial to clearly define the toxicity profile of IV HER2Bi armed T cells in patients with neoplasms of digestive system.
SECONDARY OBJECTIVES:
I. Evaluate phenotype, cytokine profiles and tumor markers, cytotoxicity directed at laboratory Her2 positive cancer cell lines.
II. Evaluate the clinical symptoms and signs, clinical responses, imaging examination of pretherapy and post-treatment, cytokine profiles and tumor markers in serum before and after treatment, time to progression, and overall survival.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Her2-positive neoplasms of digestive system: IHC 3+
- •Clinical staging: Phase III or above
- •Ages: < 65
- •Expected survival time: > 1 year
- •Quality of Life: > 60
- •The functions of important organs( heart, liver, lung, kidney and etc.)are normal
- •The volunteers with informed consent
- •Exclusion criteria:
- •Patient with Her2-negative neoplasms of digestive system
- •Hepatic renal dysfunction
- •Cardiopulmonary insufficiency
- •Mental disorder
- •Allergic condition
- •With other malignant tumor
- •Lactating women
- •Patients with infection or received chemotherapy in the past two weeks
- •Patient with autoimmune disease using immunosuppressive drug
- •Patient with organ transplantation with long term use of immunosupresive drug
排除标准
- 未提供
研究组 & 干预措施
Interleukin-2 Transfusion
Patients receive low-dose Recombinant Human Interleukin-2 SC daily beginning 3 days before the first HER2Bi armed T cell infusions infusion.
干预措施: Recombinant Human Interleukin-2 (Drug)
T Cells Transfusion
Patients receive HER2Bi-Armed T Cells IV weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: HER2Bi-Armed T Cells (Drug)
结局指标
主要结局
Safety as measured by local and systemic toxicities
时间窗: Up to 1 year
次要结局
- Changes in cytokine profiles and tumor markers in serum before and after treatment(Baseline to up to 12 months)
- Changes in phenotyping induced by immunotherapy in peripheral blood mononuclear cells (PBMC)(Baseline to up to 12 months)
- Clinical response rate (including clinical symptoms and signs, complete response, partial response, progressive disease, and stable disease, imaging examination of pretherapy and post-treatment) will be measured by follow-up investigation.(Up to 12 months)
- Overall survival(Up to 12 months)
- Progression free survival(From the beginning of immunotherapy to progression or death, assessed up to 12 months)
研究者
Yi Miao
Director of the Pancreas Research Centre; Director of Institute of Tumor Biology, Jiangsu Province Academy of Clinical Medicine
The First Affiliated Hospital with Nanjing Medical University