A Single Arm, Open, Phase I/II Clinical Study of MASCT-I Treatment for Advanced Solid Tumor
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 46
- 主要终点
- Incidence of treatment-related adverse events
研究概览
简要总结
Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) is a new immunotherapy that dendritic cells(DC) was induced from autologous peripheral blood. The DC can then be loaded with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly re-infused. The previous research data showed that MASCT had the modest overall response and less adverse effects for Hepatocellular Carcinoma patients.
The study is aimed to evaluate the safety of MASCT-1 in patients with advanced solid tumors.
详细描述
This study is divided into two stages. The first stage is the safety study in small samples, and the second stage is the sample size expansion phase.
40-50 patients with advanced or recurrent solid tumors who had failed after standard treatment will be recruited in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically-confirmed, advanced (unresectable) solid tumors（Lung cancer, colon cancer, prostate cancer, soft tissue sarcoma, other rare tumor） who have progressed on standard therapy.
- •With written informed consent signed voluntarily by patients themselves.
- •The time of between Patients enrollment and the end of other anti-tumors therapies≥1 month.
- •At least one measurable lesion as defined by RECIST criteria 1.1 for tumors.
- •Life expectancy ≥6 months.
- •With normal cardiopulmonary function.
- •Patients have adequate organ function as defined by the following criteria:
- •Hemoglobin (HGB) ≥85g/L Absolute neutrophil count (ANC) ≥1.0×10^9/L White blood cell (WBC) ≥3.0×10^9/L Platelet count ≥80×10^9/L Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) of ≤2.5 upper normal limitation (UNL) or ≤5 UNL in case of liver metastasis Alkaline phosphatase (ALP)≤2.5 UNL Total bilirubin (TBil) of ≤1.5 UNL Blood urea nitrogen (BUN) and Creatinine (Cr) of≤1.5 UNL Albumin (ALB) ≥30g/L
排除标准
- •Pregnant or expecting to pregnant
- •Participated in other clinical trials before screening except of observational study.
- •Refused to provide blood samples.
- •Known allergic history of sodium citrate drugs.
- •Known history of organ transplant, including autologous bone marrow transplantation and peripheral stem cell transplantation.
- •Known active brain metastases
- •The use of immunosuppressive drugs with current or 14 days before enrollment.
- •Active primary immune deficiency.
- •known history of tuberculosis.
- •Active infection, including hepatitis B, hepatitis C virus, or human immunodeficiency virus.
- •Patients with serious infection, hepatopathy, nephropathy, respiratory disease, cardiovascular disease or incontrollable diabetes, etc.
- •Patients have other malignant tumors within 5 years,excluding melanoma and carcinoma in situ of cervix.
- •Clinical signs of heart disease.
- •Treatment with any anti-tumors agent within 28days of first administration of study treatment.
- •The research on the influence of non legal persons, medical or ethical reasons
结局指标
主要结局
Incidence of treatment-related adverse events
时间窗: up to 2 years
The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, versio4.0
次要结局
- Overall Survival (OS)(up to 2 years)
- Objective Response Rate (ORR)(up to 2 years)
- Disease Control Rate (DCR)(up to 2 years)
- Progression-Free Survival (PFS)(From enrollment to progression of disease. Estimated about 6 months)