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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NK cells infusion | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NK cells infusion | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Successful 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 | 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. | 4 weeks after all the treatment finished |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The interval time from the date when patients are enrolled into study to death or the last visit | 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 |
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Inclusion Criteria:
1) WBC≥3×109/L, ANC≥1.5×109/L, Hb≥90g/L, PLT≥100×109/L; 2) TBIL ≤ 1.5 × ULN (normal upper limit), ALT and AST ≤ 2 × ULN (if there is liver metastasis, then ≤ 5 × ULN); 3) Endogenous creatinine clearance ≥ 60 ml/min (calculated based on Cockcroft-Gault formula); (7) Length of solid tumors do not exceed 6 cm; (8) Signing of informed consent from each patient
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueyin Pan, PhD | Contact | 86-551-62283411 | yueyinpan1965@163.com | |
| Wei Wang, MD | Contact | 86-551-62283411 | whouwei@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yueyin Pan, PhD | Anhui Province Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial cancer center | Recruiting | Hefei | Anhui | 230001 | China |
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| 1 and 2 years after treatment |
| Dynamic changes of NK cells number in blood | Numbers of CD56 positive cell in peripheral blood | Day 1,3,5,7,10,14,21,28 and 2, 3, 6 months after NK cells infusion finished |