NCT03415100Unknown1 期
Pilot Study of NKG2D-Ligand Targeted CAR-NK Cells in Patients With Metastatic Solid Tumours
The Third Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This is a single-centre, single arm, open-label pilot study to evaluate the safety and feasibility of CAR-NK cell treatment in subjects with metastatic solid tumours. Autologous or allogeneic NK cells are transfected by mRNA electroporation to prepare investigational CAR-NK cells with transiently enhanced specificity and activity against NKG2D-ligand expressing cancer cells.
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
- •Signed informed consent form must be obtained prior to any research procedure.
- •Histologically or cytologically confirmed diagnosis of metastatic solid tumours
- •ECOG performance status of 0-3;
- •Adequate organ function defined as: ANC≥1.0×10^9/L, PLT≥75×10^9/L, ALB≥25g/L, TBIL≤1.5×ULN, AST≤2.5×ULN, ALT≤2.5×ULN, ALP≤2.5×ULN, Cr≤1.5×ULN;
- •The patient's own PBMCs or PBMCs from a biological parent or child who is willing to donate blood will be used to prepare CAR-NK cells. The parent or child should be ≥18 and ≤60 years old, and he or she is able to sign the informed consent for blood donation by himself/herself;
- •Patients who won't benefit from surgery, or refuse surgical treatment; patients who won't benefit from chemotherapy, can't tolerate chemotherapy or refuse chemotherapy.
- •Patients volunteer to participate in this study and sign the informed consent form for subjects;
- •Blood donors sign the informed consent form for blood donors.
- •Blood donors have negative test results for HIV, HBV and HCV;
- •If a subject or blood donor is a female of childbearing potential, she must have a negative urine pregnancy test result.
排除标准
- •Patients who are suffering from uncontrollable or active infectious diseases of the hematological system, cardiovascular system, respiratory system, digestive system, urinary system, or the endocrine system;
- •Patients with immunologic deficiency or autoimmune diseases;
- •Patients with severe hypersensitivity reactions;
- •Patients received other forms of cellular therapies within the last 3 months;
- •Patients received systemic steroids within the last 3 months;
- •Patients who are breastfeeding or pregnant;
- •Patients with brain metastases;
- •Patients who have received an organ transplant.
研究组 & 干预措施
CAR-NK cells targeting NKG2D ligands
Experimental
干预措施: CAR-NK cells targeting NKG2D ligands (Biological)
结局指标
主要结局
Number of Adverse Events
时间窗: from day 0 - month 4
次要结局
- Anti-tumour response due to CAR-NK cell infusions(100 days after CAR-NK cell infusion)
研究者
研究点 (1)
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