Small Cell Lung Cancer (SCLC) Clinical Trials

• 1.Trial articipant must be ≥ 18 years and ≤75 years of age at the time of signing the ICF.

∙ Type of Subjects and Disease Characteristics

• 2.ECOG performance status 0-2.

• 3.Life expectancy ≥ 12 weeks.

• 4.At least 1 TL meeting RECIST v1.1 at screening. Tumor assessment by CT scan or MRI must be performed within 28 days prior to apheresis.

‣ A lesion can be considered TL if the lesion previously subjected to radiotherapy has a clear boundary, is measurable as per RECIST v1.1, and has clear progression during or after the latest treatment;

⁃ If a fresh biopsy sample is selected at screening from a tumor lesion, the tumor lesion should not be selected as a TL unless imaging is performed at least approximately 2 weeks after the biopsy to allow time for healing. In a case where there is only one measurable TL, caution should be taken when obtaining biopsy tissues during the treatment period.

• 5.Archival or freshly biopsied tumor tissue for assessment of DLL3 expression levels can be provided.

• 6.Adequate organ function:

• a.Blood function: i.Hemoglobin ≥ 9 g/dL (without transfusion or erythropoietin therapy within 2 weeks prior to screening assessment); ii.Absolute neutrophil count ≥ 1.5×10\^9/L and absolute lymphocyte count ≥ 0.6×10\^9/L (without G-CSF use within 2 weeks prior to screening assessment);iii.Platelet count ≥ 75×10\^9/L (without platelet transfusion or recombinant human thrombopoietin within 2 weeks prior to screening assessment).

• b.Hepatic function (based on normal values as defined by the clinical study site):i.Serum TBL ≤ 1.5 ×ULN;ii.ALT or AST ≤ 2.5×ULN in the absence of liver metastases; ALT and AST ≤ 5×ULN in the presence of liver metastases.

• c.Renal function (based on normal values as defined by the clinical study site): i.Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/minute calculated using the Cockcroft-Gault formula, or creatinine clearance ≥ 60 mL/minute calculated using 24-hour urine.ii.Urine protein \<++. For trial participants with proteinuria ≥ ++ on urine test paper at baseline, 24-hour urine must be collected and the content of protein in urine within 24 hours must be \< 1 g.

• d.Coagulation function (based on normal values as defined by the clinical study site):i.PT≤1.5×ULN；ii.Thrombin time ≤ 1.5×ULN;iii.aPTT≤1.5×ULN。

• e.Cardiac function:i.New York Heart Association classification \< class 3;ii.LVEF ≥ 50%.

• 7.Able to establish venous access and, in the judgment of the investigator, suitable for PBMC collection.

• 8.Women of childbearing potential must be non-lactating, and women of childbearing potential must have a negative result of highly sensitive serum pregnancy test during screening.

• 9.All trial participants of childbearing age (including women of childbearing age and males with partners) must agree to take medically acceptable effective contraception measures as mentioned in Appendix F throughout the treatment period and for 2 years after the last CAR-T product reinfusion or until a negative CAR copy test, whichever occurs later.

• 10.Male trial participants must agree not to donate sperm and female trial participants must agree not to donate eggs throughout the treatment period and for 2 years after the last CAR-T product reinfusion or until a negative CAR copy test, whichever occurs later.

• 11.Capable of signing ICF (as mentioned in Appendix A), which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

• 12.The trial participant has provided ICF before starting any study-specific activity/procedure.

• 13.Able to communicate well with the investigator, and willing to comply with the study plan and able to complete the study as required.