NCT03366064已完成1 期
Phase I Trial of Haploidentical Natural Killer (NK) Cells in Combination With Pemetrexed in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- maximum tolerated dose of donor NK cells
研究概览
简要总结
This phase 1 trial investigate safety and maximum tolerated dose of natural killer (NK) cells derived from haploidentical family donors in patients with non-small cell lung cancer
详细描述
Eligible patients receive pemetrexed 500 mg/m2 intravenously (Day 1). On Day 8, patients receive donor-derived NK cells via a central venous catheter.
The NK cell dose is as follows;
Level 1: 1.25 X 109 cells Level 2: 2.50 X 109 cells Level 3: 5.00 X 109 cells
Three patients each will be treated on each dose level.
Two weeks prior to donor NK cell administration to patients, HLA-haploidentical family member of the patients undergo leukapheresis after G-CSF injections to collect hematopoietic stem 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed non-small cell lung cancer stage 4 (by AJCC 7th)
- •Age, 20 years of age or older
- •ECOG performance status, 0-2
- •Life expectancy ≥3 months
- •Patients should have at least one measurable lesion according to RECIST Criteria v1.1
- •Failure after primary systemic treatment with a regimen including platinum-containing agent (primary systemic treatment may be adjuvant chemotherapy or chemo-radiotherapy, given within 12 months)
- •Adequate bone marrow function (Hb ≥9 g/dL; ANC ≥1,500/uL; and platelet count ≥75,000/uL)
- •Adequate renal function (serum creatinine <1 x ULN or CLcr ≥45 mL/min by Cockroft and Gault formula
- •Adequate liver function (total bilirubin <1.5 x ULN; AST and ALT <3 x ULN; and ALP <3 x ULN, unless there is bone metastases without evidence of liver disease)
- •Patients should have a suitable HLA-haploidentical family member who is willing to donate hematopoietic stem cells
- •Patients should sign informed consent voluntarily
排除标准
- •Patients who received anti-cancer chemotherapeutic or biological agents within 3 weeks. Patients who received anti-cancer treatment and did not recover from toxicities to grades 0-1 by NCI CTC AE ver 4.0 are not eligible as well.
- •Patients with contraindication for any medication planned to be administered in the study
- •Patients with significant fluid accumulation in third space (for example, pleural or pericardial effusion) that can not be controlled by drainage
- •Active infectious process
- •Inability to discontinue aspirin over 1.3 g daily or other NSAIDs. Patients cannot take aspirin or NSAIDs within 5 days of pemetrexed administration
- •Major surgery within 4 weeks of study participation
- •Palliative radiation therapy within 1 week of study participation
- •Acute myocardial infarction within 6 months of study participation. History of uncontrolled arrhythmia, symptomatic angina, or symptomatic heart failure
- •Past or current history of CNS metastasis (with exception of those patients who completed treatment of CNS metastasis and not received steroid treatment or whole brain radiotherapy within 2 weeks of screening visit or not received gamma knife treatment within 1 week of screening visit)
- •History of malignancy (other than skin basal cell carcinoma, carcinoma in situ of uterine cervix, or thyroid cancer) within 5 years
- •Pregnant or lactating women. Child-bearing women who are not willing to avoid pregnancy by contraceptives
- •Man not agreeing to contraceptive measures such as condom or abstinence (It is recommended that contraceptive measures be used until 6 months after pemetrexed treatment)
- •Other serious illness or medical condition
研究组 & 干预措施
Pemetrexed and donor NK cell infusion
Experimental
Eligible patients with stage 4 non-small cell lung cancer receive NK cells derived from HLA-haploidentical family donors. One week prior to NK cell infusion, patients receive pemetrexed (500 mg/m2) intravenous infusion
干预措施: Pemetrexed and donor-derived NK cell infusion (Biological)
结局指标
主要结局
maximum tolerated dose of donor NK cells
时间窗: 6 weeks
determine the dose of NK cells that can be given within dose-limiting toxicities
次要结局
未报告次要终点
研究者
Kyoo-Hyung Lee
Professor, Hematology
Asan Medical Center
研究点 (2)
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