This study is designed to explore the safety and efficacy of natural killer (NK) cell infusion as treatment for patients with advanced malignant tumors after multiline therapy, and to evaluate the pharmacokinetics of NK cells in patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Pretreatment:patients enrolled in this study will receive 20 mg/kg of cyclophosphamide for solid tumor or 20-60 mg/kg of cyclophosphamide for hematological tumor once daily for 3 times. NK cells infusion is allowed within 2-14 days after treatment. NK cells infusion:30-60 minutes before infusion,ant-allergic agents are applied (promethazine 25mg,i.m. ; Cimetidine 0.4g i.v. ; diphenhydramine 50mg po.). NK cells are intravenously infused into patients with 15-30 minutes every other day for one to three times. The number of every infused NK cells is 1-3×10\^7/kg, counted as the number of CD56+ cells. Patients with severe pleural or ascites can also receive pleural or abdominal cavity perfusion simultaneously. The total number of infused NK cells is no more than 5×10\^9 cells. 4 hours after NK cells infusion,IL-2 is applied every other day for six times
Anhui Provincial cancer center
Hefei, Anhui, China
RECRUITINGSuccessful expansion of NK cells in patient's circulatory system
CD56 positive cells ≥100 cells/μL in blood is considered as successful expansion of NK cells
Time frame: 7 days after the last treatment
Objective Response Rate
The percentage of patients who reach complete response(CR)or partial response (PR)after all treatment finished. The response is evaluated according to irRECIST.
Time frame: 4 weeks after all the treatment finished
Overall survival
The interval time from the date when patients are enrolled into study to death or the last visit
Time frame: 1 and 2 years after treatment
Disease progression free survival
The interval time from the date when patients are enrolled into study to disease progression, death or last visit
Time frame: 1 and 2 years after treatment
Dynamic changes of NK cells number in blood
Numbers of CD56 positive cell in peripheral blood
Time frame: Day 1,3,5,7,10,14,21,28 and 2, 3, 6 months after NK cells infusion finished
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