Phase I Clinical Study of α-PD-L1/DLL3 CAR-T in Patients With R/R SCLC

Inclusion Criteria:

• Patients with recurrent or refractory small cell lung cancer (SCLC) confirmed byhistology or cytology who have relapsed or progressed after treatment with oneprevious platinum-based regimen;

• Patients can provide sufficient tumor tissue (fresh or paraffin sections, etc.);

• Age 18 ~70 (including boundary), for both men and women;

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

• Life expectancy ≥3 months;

• At least one extracranial measurable lesion (RECIST v1.1) exists；for lesion afterradiotherapy， must be confirmed that the lesion has progressed ;

• Patients in limited-stage at the initial diagnosis must undergo radical thoracicradiotherapy and the time of tumor progression is not less than 3 months from theend of radiotherapy, or radical thoracic dose radiotherapy cannot be performed forspecific reasons;

• The test results of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C and syphilis were negative at screening;

• Female patients or male reproductive age patients and their partners should agree toeffective contraception from sighing Informed Consent Form (ICF) to 6 months afterthe last BHP01 infusion.

Exclusion Criteria:

• Patients with known primary Central Nervous System (CNS) tumor, or meningealmetastasis, or patients with unstable CNS metastasis (symptomatic, requiringhormonal therapy within 4 weeks before investigational treatment, or no radiographicevidence of stabilization of the lesion for more than 4 weeks);

• Received major surgical procedures （except for diagnosis） within 4 weeks beforePBMCs collection, or are expected to require major surgical procedures during thestudy;

• Received Chinese herbal medicine or Chinese patent medicine for anti-tumorindications within 7 days before Peripheral Blood Mononuclear Cells (PBMCs)collection;

• Patients with a history of idiopathic pulmonary fibrosis, mechanical pneumonia (suchas bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia, orevidence of active pneumonia by chest computer tomography (CT) at screening [ahistory of radiation pneumonia (fibrosis) in the irradiated field may participate inthis study];

• Poorly controlled pleural effusion, pericardial effusion, or ascites requiringrepeated drainage procedures (once a month or more frequently);

• Poorly controlled or symptomatic hypercalcemia (ionic calcium> 1.5 mmol/L, calcium> 12 mg/dL or corrected calcium> ULN);

• Presence of active or previous autoimmune diseases or immunodeficiencies, includingbut not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupuserythematosus, rheumatoid arthritis, etc.;

• Severe infection within 4 weeks before the start of PBMCs collection, including butnot limited to hospitalization due to infection, bacteremia, severe pneumonia, orany active infection that may affect the patient's safety;

• Serious cardiovascular and cerebrovascular diseases (such as heart disease ≥New YorkHeart Association class II, myocardial infarction or cerebrovascular accident),unstable arrhythmia or unstable angina pectoris within 3 months before PBMCscollection;

• Previous treatment with DLL 3 target drugs or CAR-T or other gene-modified T cells;

• Received any other Investigational drug within 28 days prior to PBMCs collection;

• A history of mental illness;

• Incapacitated persons or persons with limited capacity;

• pregnant or lactating females; Males or females who are unwilling to use adequatecontraception; Females of childbearing potential are required to undergo a pregnancystudy during the screening period;