NSCLC
Conditions
Interventions
experimental group:PD-1 antibody-blocked autologous RAK cells
Sponsors
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, regardless of gender. 2. Advanced (stage IIIb) or metastatic (stage IV) non-small cell lung cancer. 3. Provide detectable specimens (tissue or pleural fluid specimens) for PD-L1 expression detection and genotyping (PD-L1 positive rate is not required) before entering the group, and the results of EGFR sensitive mutation, ALK fusion and ROS1 fusion gene detection are negative Of patients; or patients whose test results are positive and have progressed after receiving relevant targeted drug therapy. 4. According to the RECIST 1.1 standard, there is at least one measurable lesion, and the lesion has not received radiotherapy. 5. The patient has previously received standard first-line or above systemic treatment and the treatment has failed (Note: After the first-line treatment fails, if there is second-line standard treatment, the patient is first recommended to take the second-line standard treatment. If the patient cannot tolerate or refuse the second-line treatment, he can enter Group this study). 6. The ECOG score is 0 to 1 points. 7. Women of childbearing age must have a negative serum pregnancy test result within 7 days before the first use of the test drug; males with reproductive capacity or women who may become pregnant must use highly effective contraceptive methods (such as oral contraceptives, Intrauterine contraceptives, sex control or barrier contraception combined with spermicide), and continue contraception for 12 months after the end of treatment. 8. Have proper venous access: consider PICC or other central lines. 9. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Have received other immune checkpoint inhibitors or adoptive cell therapy (ACT) treatment. 2. Simultaneous application of other anti-tumor drugs. Received anti-tumor therapy such as chemotherapy, radiotherapy, targeted therapy or major surgery within 3.4 weeks. 4. Past history of other malignant tumors. 5. Those who are known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components. 6. Active and untreated central nervous system (central nervous system) metastases (including metastases found in MRI or CT scans). Asymptomatic, treated patients with metastatic disease, or whose lesions show stability for more than 2 months, are eligible. 7. Active lung disease (interstitial pneumonia, pneumonia, obstructive lung disease, asthma) or active tuberculosis. 8. Previously diagnosed patients with autoimmune diseases, patients with immunodeficiency (primary or secondary) or using drugs that affect immune function. 9. Significant cardiovascular abnormalities defined by any of the following: (1) Congestive heart failure NYHA Class II-IV. (2) Clinically significant hypotension. (3) Symptoms of coronary artery disease. (4) Arrhythmia requiring medication. 10. There is organ dysfunction: platelet count 1.5 x ULN or calculated value of creatinine clearance = 2.5 x ULN , Bilirubin >= 2.0 x ULN. 11. The following conditions occurred within 6 months before medication: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass Transplantation; cerebrovascular accident, transient ischemic attack, cerebral embolism. 12. Have received allogeneic hematopoietic stem cell transplantation or organ transplantation 13. The patient has mental illness or no self-judgment ability. 14. The investigator's judgment may increase the risks associated with participating in the study, or other severe, acute or chronic medical diseases or laboratory abnormalities that may interfere with the interpretation of the study results. 15. The investigator judges that the compliance is poor, or there are other conditions that make the patients unsuitable to participate in this trial. 16. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and maximum tolerated dose; | — |
Countries
China
Contacts
Public ContactXingsheng Hu
National Cancer Center /Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed