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

Korábbi kezelés

• 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).
• Participated in other intervention clinical studies within 4 weeks before screening;

Más betegség

• 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).
• 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.
• Active systemic autoimmune disease is known before screening and is under treatment.
• 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.
• People who are allergic to IL-2.

Laborértékek

• 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;
• People who are allergic to human blood albumin.

Egyéb

• Patients who are judged by the investigator to be unsuitable for participating in this study.

• Willingness to provide informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• Age ≥18 years old and ≤ 75 years old at the time of signing the ICF
• Have cytologically or histologically confirmed diagnosis for the patients with locally advanced unresectable or metastatic small cell lung cancer.
• Have measurable disease as assessed by the investigator according to RECIST 1.1.
• Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
• Have a life expectancy of ≥ 3 months.
• Female participants: Women of childbearing potential (WOCBP) must use a highly effective form of contraception from the screening visit until at least 12 months after the final dose of iNK cells.
• Male participants: Males must be sterile (biologically or surgically) or use a highly effective method of contraception from the screening visit until at least12 months after the final dose of iNK cells.