LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer

Inclusion Criteria:

• signed informed consent;

• ≥18years, male or female;

• cohort1: Histologically/cytologically confirmed locally advanced or metastasticNon-small lung carcinoma (NSCLC), and received systemic treatment forrecurrence/metastasis ≤3 lines; cohort2: Histologically/cytologically confirmedextensive small-cell lung carcinoma (ES-SCLC); Cohort 1 and Cohort 2 requiredpatients progressed/recurrenced after anti-PD-1/PD-L1treatment;

• Cohort 3: Histologically/cytologically confirmed locally advanced or metastaticnon-small cell lung cancer (NSCLC) with no driver gene mutation and have PD-L1expression, and who have not experienced disease progression after receivingchemotherapy combined with an anti-PD-1 therapy.

• Life expectancy of more than 3 months;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1;

• At least one measurable lesion according to RECIST 1.1;

• The sequencing of tumor were qualified;

• According to the invistigators' judgment, venous vascular conditions can meet theneeds of apheresis;

• For adequate organ function, the patients need to meet the following laboratoryindexes:

• hematologic functions(No blood transfusion or treatment with blood componentsand without granulocyte colony stimulating factor in the past 14 days.):

• the absolute value of neutrophils (ANC) ≥ 1.5x109/L;

• the platelet count was ≥ 90x109/L;

• the hemoglobin > 9g/dL;

• Hepatic functions:

• Total bilirubin ≤ 1.5 × normal upper limit (ULN); patients with livermetastasis allow ≤ 3 × ULN;

• aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (patients with liver metastasis allow ALT or AST ≤ 5 × ULN);

• renal

• Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated byCockcroft-Gault formula) ≥ 50ml;

• patients with urinary protein ≥ + + and confirmed 24-hour urinary proteinquantity > 1.0g;

• Coagulation function is good, defined as international standardized ratio (INR)or prothrombin time (PT) ≤ 1.5 times ULN;

• Normal thyroid function is defined as thyroid stimulating hormone (TSH) withinthe normal range. If the baseline TSH is beyond the normal range, subjects withtotal T3 (or FT3) and FT4 within the normal range can also be enrolled;

• FBG of patients without type 2 diabetes ≤ 126 mg/dL or ≤ 7.0 mmol/L, and that ofpatients with type 2 diabetes ≤ 167 mg/dL or ≤ 9.3 mmol/L; Or glycosylatedhemoglobin (HbA1c) ≤8%;

• If there is a risk of pregnancy, all patient (male or female) are required to takeappropriate methods for contraception during the study until the 6th month post thelast administration of study drug;

• Well compliance, cooperate with follow-up;

Exclusion Criteria:

• History of hypersensitivity reaction to any vaccine and/or anti-PD-1/PD-L1formulation ingredients; Or have had a previous severe allergic reaction to othermonoclonal antibodies; Subjects who had previously discontinued anti-PD-1 /PD-L1therapy due to "infusion reaction" or immune-related AE;

• Patients who have received therapeutic tumor vaccine products (including peptidevaccine, mRNA vaccine, DC vaccine, etc.);

• Diagnosis of malignant diseases other than study disease within 5 years beforescreening (except for malignant tumors that can be expected to recover aftertreatment);

• Patients received systemic antitumor treatment within 2 weeks before the apheresis,or receive reasearch drugs or device therapy;

• Received radiotherapy within 2 weeks prior to screening;

• Toxicity caused by previous treatment did not recover to CTCAE (version 5.0) Grade 1or below (except hair loss and peripheral neuropathy);

• The tumor compresses the surrounding important organs or the superior vena cava, orinvades the mediastinal great blood vessels, the heart, .etc;

• Patients who have recewived allogeneic hematopoietic stem cell transplantation ororgan transplantation;

• A history of medical conditions that may trigger seizures (requiring treatment withantiepileptic medications);

• Patients who have active brain metastases or cancerous meningitis. Patients withtreated brain metastases are eligible if they have been treated with brainmetastases, and clinically stable for atleast 3 months, no evidence of diseaseprogression 4 weeks before. All neurological symptoms had recovered, and offsteroids at least 7 days prior to screening;

• Diaginosied or suspected of having an active autoimmune disease;

• patients with poorly controlled pleural effusion, pericardial effusion, or ascitesrequiring repeated drainage, or received pleural effusion or ascites treatmentwithin the past 3 months;

• History of significant cardiovascular and cerebrovascular disease occurred in the 6months prior to screening,Any of the following cardiac criteria:

• Mean resting corrected QT interval (QTc) > 470 ms;

• Left ventricular ejection fraction (LVEF) ≤ 50%;

• American New York heart association (NYHA) heart function ≥ 2 or higher;

• serious arrhythmia;

• poorly controlled hypertension;

• other serious heart disease;

• Patients with interstitial pneumonia, except those inactive and do not requirehormone therapy disease;

• Patients diagnosed with active infections that are poorly controlled by systemictreatment;

• Any of the following test results are positive: human immunodeficiency virus (HIV)antibody, treponema pallidum antibody, hepatitis C virus (HCV) antibody, hepatitis Bvirus (HBV) surface antigen (HBsAg), HBV DNA and novel coronavirus nucleic acid;

• Active tuberculosis (TB) during screening;

• Treatment with systemic steroids or other immunosuppressive agents within 14 daysprior to screening;

• Vaccination within 4 weeks prior to screening;

• Major injuries and/or surgery =< 4 weeks prior to screening;

• Persons with a history of psychotropic substance abuse and inability to abstain orwith a history of mental disorders;

• Pregnant or lactating women;

• Skin diseases, such as psoriasis, may prevent intradermal vaccines from reaching thetarget area;

• Other conditions regimented at investigators' discretion.