KCT0003815招募中未知
Investigator Clinical Phase 1/2 Study of Immunotherapy Using Autologous Killer Cell in Patients with Recurrent Glioblastoma
Bundang CHA General Hospital0 个研究点目标入组 23 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 69(Year)（—）
- 性别
- All
入选标准
- •1. Individuals aged 20 years to 69 years
- •2. Individuals for whom the standard therapy failed after being diagnosed with recurrent glioblastoma based on an MRI scan
- •3. Individuals whose survival period is at least 3 months
- •4. Individuals with an appropriate bone marrow function
- •- Hemoglobin count = 10 g/dL
- •- Leukocyte count = 3,000/mm3
- •- Absolute neutrophil count = 1,500/ML
- •- Platelet count = 75.000/mm3
- •5. Individuals with appropriate liver and kidney functions
- •- Total bilirubin = 1.5 times the normal upper limit specified by the testing agency
- •- AST, ALT = 2.5 times the normal upper limit specified by the testing agency
- •- Alkaline phosphatase = 1.5 times the normal upper limit specified by the testing agency
- •- Normal kidney function (serum creatinine = normal upper limit specified by the testing agency)
- •6. Individuals who have obtained a sufficient explanation of the purpose and details of the clinical trial and the characteristics of the investigational drug from an investigator and who signed the consent form or had a legal guardian or representative sign the consent form prior to the beginning of the clinical trial
- •7. In the case of women, they must have been tested negative in a urine or blood test for pregnancy seven days before the beginning of the clinical trial and agreed to use an appropriate method of contraception during the clinical trial
- •8. Individuals who have not had any blood infection within the last 6 months
- •9. Individuals who have not received any other forms of immunotherapy
排除标准
- •1. An individual who is deemed to have a severe cardiopulmonary dysfunction by an investigator
- •2. An individual with immune deficiency or an autoimmune disease that may be exacerbated by immunotherapy (e.g. rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, juvenile-onset insulin-dependent diabetes mellitus, etc.)
- •3. A carrier of chronic hepatitis B and/or C or who is HIV antibody positive
- •4. An individual with history of severe allergic reactions
- •5. An individual with uncontrolled hypertension or diabetes
- •6. A pregnant or lactating woman
- •7. An individual who is considered to be unfit for the clinical trial due to a serious medical or psychiatric condition
- •8. An individual with a major hemorrhagic disease not associated with cancer
- •9. An individual who has participated in another clinical trial within 4 weeks before the start of this clinical trial
研究者
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