The Safety Evaluation of Ex Vivo Activated Haploidentical Natural Killer Cells (NK) in Recurrent Glioblastoma Multiform Patients (Clinical Trial Phase I)
试验速览
- 阶段
- 1 期
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Safety evaluation
研究概览
简要总结
Glioblastoma multiform is one of the most invasive and deadly cancers that progresses rapidly and leads to death. Surgery with radiotherapy /chemotherapy, as a treatment approach is ineffective in some cases and is associated with relapse and death. Immunotherapy is a special strategy that used as an adjunct therapy in various cancers and among the various methods of immunotherapy; it seems that cell therapy with NK cells is of special importance. A previous study conducted at the Royan Research Institute showed that NK cell proliferation and amplification resulted in the removal of glioblastoma tumor masses in the animal model. The animals had no evidence of tumor recurrence after treatment, and all tumor-related complications resolved after treatment. Therefore, in this study, the investigators intend to evaluate the safety of ex vivo activated cells in 5 patients with glioblastoma multiform whose disease has returned after treatment and who have not had any appropriate treatment.
详细描述
1- patient selection 2- leukapheresis 3- CD56+ cells isolation 4- NK cells activation 5- assessment of functionality and purity 6- quality control tests 7-NK cell injection in tumor cavity.
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
- 3 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 3-60 Year -
- •Sex: Both
- •Lansky performance scale/Karnofsky performance scale: 70-100%
- •Life span expectation: >6 months
- •Hemoglobin: > 10.0 g/dl
- •Platelet count > 100,000/mm³
- •Serum total bilirubin < 1.5 times upper limit of normal (ULN)
- •ALT and AST < 2.5 times ULN
- •Serum creatinine < 1.5 times ULN
- •No diagnosis of any other invasive cancer within the past 5 years.
- •No concurrent serious medical or psychiatric illness that may interfere with giving informed consent or conducting this study
排除标准
- •Patients whose MRI and MRS images is in favor of radio necrosis.
- •Due to emergency conditions, the patient cannot tolerate the new treatment
- •Lack of a suitable donor or insufficient number of NK cells.
- •Development of a new neurological defect after the first injection
- •Patient death during surgery
- •Closing the reservoir for the next injection (if this problem is resolved, the injections will be done again).
研究组 & 干预措施
Test group
The investigators will inject the activated NK cells, 1-3 times with weekly interval into tumor cavity.
干预措施: NK cell therapy (Biological)
结局指标
主要结局
Safety evaluation
时间窗: From injection time point up to 8 weeks
Safety evaluated by assessing the medical symptoms measurement: Loss of consciousness
MRI and MRS from the tumor region
时间窗: 1 months after last dose of NK cell injection up to 1 year each 3 months
Defined tumoral residua and tumor cell recurrence
Toxicity assay
时间窗: 4 weeks of last injection
Toxicity as assessed by NCI CTCAE version 3.0
Adverse Events (AEs)
时间窗: 1 year
Defined as the number and severity of adverse events
Safety evaluation
时间窗: From injection time point up to 48 hours
Safety evaluated by assessing the medical symptoms measurement: Fever, Hysteria and Convulsion
Safety evaluation
时间窗: 2 months after injection
Safety evaluated by assessing the medical symptoms measurement: Meningitis, Neurological disorders
次要结局
- Patient survival(After surgery up to an average of 1 year)