Treatment of Malignant Tumors With Antigen Peptide-specific DC-CTL Cells and Decitabine
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Tumor-specific antigens can be induced by demethylation drugs. Antigen-targeting DC-CTL cells supposed to eliminate cancer cells efficiently and specifically. In this study investigators co-culture DCs cells with peptides derived from tumor specific antigen to generate antigen-specific DC-CTLs (Ag-CTL). Following treatment with demethylation drugs, Ag-CTL will be used to eliminate tumor cells. This study aims to evaluate the effectiveness and safety of Ag-CTL combined with demethylation drugs.
详细描述
A large number of studies have confirmed that demethylated drug decitabine can effectively induce tumor-specific antigen expression. Tumor-specific antigens have strong specificity and are ideal therapeutic targets. In this study, tumor-specific antigens were used as therapeutic targets. The researchers screened the tumor-specific epitope peptides through bioinformatics database combined with in vitro experiments. The peptide-loaded DCs are co-cultured with T lymphocytes to induce the proliferation of CTLs, which are then refusion to tumor patients to treating diseases.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18-70 (including 18 and 70 years old);
- •Diagnosed as malignant tumor by pathological and histological examination;
- •Patients with ECOG score <2 and estimated survival time>3 months;
- •Patients need to receive systemic combined chemotherapy according to their condition; other treatments such as surgery, radiotherapy, and targeted therapy are excluded;
- •The previous treatment-related toxicity of the patient 2 weeks before the enrollment had returned to <1 grade at the time of enrollment (except for low-grade toxicity such as alopecia and peripheral neuritis);
- •The patient's intravenous access is unobstructed, which can meet the needs of intravenous drip;
- •The patient voluntarily participates and signs the informed consent form, and follows the research treatment plan and visit plan;
排除标准
- •Any one of the exclusion criteria shall not be included in the group:
- •Patients used high-dose hormones within 1 week before enrollment (except for patients using inhaled hormones)
- •People with severe autoimmune diseases, immunodeficiency diseases or severe allergies;
- •Patients treated with other cellular immune products (DC, T, NK, and CAR-T, etc.);
- •The patient had uncontrollable infections within 4 weeks before enrollment;
- •Active HBV DNA>1000copy/mL/C hepatitis (anti-HCV positive, HCV RNA positive), HIV positive, syphilis positive;
- •The patient participated in other clinical studies within 6 weeks before enrollment;
- •Patients suffering from mental illness;
- •The patient has drug abuse/addiction and medical, psychological or social conditions that may interfere with research or have an impact on the evaluation of research results;
- •The patient has alcohol dependence;
- •Women who are pregnant (positive urine/blood pregnancy studies) or breastfeeding; men or women who have a pregnancy plan within the past year; patients cannot be guaranteed to take effective contraceptive measures during the study period;
- •According to the judgment of the investigator, the patient has other unsuitable conditions for enrollment.
结局指标
主要结局
PFS
时间窗: From date of initial treatment until the date of first documented progression, assessed up to 36 months.
progression free survival time
次要结局
- OS(From date of diagnosis until the end of the follow-up, assessed up to 36 months.)
研究者
YuLi
Professor
Shenzhen University General Hospital