Lung Cancer Clinical Trials

• All participants must be informed of the trial before any examinations stipulated in this trial are initiated, voluntarily sign the written informed consent form (ICF) approved by the ethics committee, and be able to comply with the research procedures.

• Age ranges from 18 to 70 years old (including threshold), regardless of gender.

• For participants diagnosed with primary NSCLC according to the standards of the Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer(2024 edition) and the Clinical Practice Guideline for Primary Lung Cancer(2022 Version), and who have undergone radical surgical resection (R0) treatment, the TNM stage is classified as stage IIA - IIIB according to the American Joint Committee on Cancer staging system(AJCC),9th edition.

• There is no disease recurrence (including local recurrence) after radical surgical resection (R0) treatment, and the estimated time of apheresis is within one year after the operation.

• Previous tests for driver gene mutations (e.g., EGFR, ALK) were negative, and PD-L1 expression in tumor tissues was negative as detected.

• Platinum-based chemotherapy (one to four cycles) has been completed before screening.

• The ECOG performance status score is ≤1 point, the expected survival time is ≥12 months, and follow-up can be conducted as stipulated in the protocol.

• Major organ functions must be normal (no corrective treatment with any blood components, cell growth factors, or albumin infusion within 14 days before obtaining laboratory tests) and meet the following requirements: White blood cells (WBC) ≥3.5×109 cells/L, lymphocytes (LYM) ≥0.8×109 cells/L, platelets (PLT) ≥80×109 cells/L, absolute neutrophil count ≥1.5×109 cells/L, hemoglobin ≥90g/L; Total bilirubin ≤1.5×upper limit of normal value (ULN), alanine aminotransferase (ALT) ≤2.5×ULN, aspartate aminotransferase (AST) ≤2.5×ULN; Creatinine ≤1.0×ULN, or creatinine clearance rate ≥60mL/min (using the Cockcroft-Gault method); International Normalized Ratio (INR) ≤1.5.

• Participants must have sufficient venous access for the apheresis.

⁃ Eligible participants with fertility (both male and female) must agree to use reliable contraceptive methods (hormones or barrier methods or abstinence) during the trial and for at least one year after the last reinfusion of SDTM001 injection; Female participants within childbearing age must have a negative pregnancy blood test within 7 days prior to enrollment; Male participants were not allowed to donate sperm from the first infusion to one year after the last infusion.