INK Cells As Maintenance Therapy After Chemoradiotherapy for Small Cell Lung Cancer

Exclusion Criteria

• •1. Has evidence of insufficient organ function. 1.1 Has active or clinically significant cardiac disease including: 1.1.1 Severe heart rhythm or conduction abnormalities, corrected QT interval (QTc) ≥ 480 ms.
• •1.1.2 Complete left bundle branch block, second- or third-degree atrioventricular block.
• •1.1.3 Severe, uncontrolled cardiac arrhythmias requiring medication. 1.1.4 New York Heart Association (NYHA) class II or above congestive heart failure.
• •1.1.5 Left ventricular ejection fraction (LVEF) \< 50% in color Doppler echocardiography.
• •1.1.6 History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, severe pericardial disease, ECG evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment.
• •1.2 Renal: SCR \> 1.5 x ULN or calculated creatinine clearance (Cockcroft-Gault Formula) \<60 mL/min.
• •1.3 Liver: 1.3.1 total bilirubin \> 1.5 x ULN. 1.3.2 AST\>2x ULN or ALT\>2x ULN. AST/ALT can be as high as 5× ULN in liver metastases, but it cannot be accompanied by elevated bilirubin 1.4 lung:
• •\> grade 1 dyspnea and oxygen saturation ≤ 91% in non oxygen breathing state. 1.5 Hematological: 1.5.1 Absolute neutrophil count (ANC) \< 1.5 x 109/L. 1.5.2 Platelet count\< 100 x 109/L. 1.5.3 Hemoglobin \< 9.0g/dL. 1.5.4 International normalized ratio (INR) \> 1.5 times ULN, and activated partial prothrombin time (APTT) \> 1.5 times ULN;
• •2. At the time of screening, patients with symptomatic central nervous system (CNS) metastases (asymptomatic CNS metastases, or asymptomatic after local treatment and stable condition for 4 weeks can be enrolled).
• •3. Those with a history of central nervous system before screening, such as epilepsy, cerebral ischemia / hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, cerebral organic syndrome, mental disease or any autoimmune disease involving the central nervous system.
• •4. Those who stopped systemic hormone therapy for less than 72 hours before cell transfusion; But it is allowed to use a physiological substitute amount of hormone (such as prednisone \< 10mg / D or equivalent).
• •5. Active systemic autoimmune disease is known before screening and is under treatment.
• •6. 8\. Those who meet any of the following conditions during screening: 6.8.1 Positive for hepatitis B surface antigen (HBsAg) and / or hepatitis B e antigen (HBeAg).
• •6.8.2 Hepatitis B e antibody (HBE AB) and / or hepatitis B core antibody (HBC AB) are positive, and the copy number of HBV-DNA is greater than the lower measurable limit.
• •6.8.3 Positive for hepatitis C antibody (HCV AB). 6.8.4 Positive anti Treponema pallidum antibody (TP AB). 6.8.5 HIV antibody test positive. 6.8.6 The copy number of EBV-DNA and cmv-dna is greater than the lower measurable limit.
• •7. Participated in other intervention clinical studies within 4 weeks before screening;
• •8. People who are allergic to human blood albumin.
• •9. People who are allergic to IL-2.
• •10. Patients who are judged by the investigator to be unsuitable for participating in this study.