[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542894":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":57,"collaborators":60,"id":64,"slug":32,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":32,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":32,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Sichuan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"α-PD-L1\u002F4-1BB DLL3 CAR-T (BHP01) Treatment","EXPERIMENTAL","The Patients enrolled will be sequentially assigned to the corresponding dose level, BHP01 was administered intravenous infusion at different cell dose levels. The patients were received multiple-dose infusion according to investigator's evaluation.",[13],"Drug: α-PD-L1\u002F4-1BB DLL3 CAR-T (BHP01)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","α-PD-L1\u002F4-1BB DLL3 CAR-T (BHP01)","Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses; Bridge radiotherapy with 15 Gray (Gy)\u002F5 fractions; α-PD-L1\u002F4-1BB DLL3 CAR-T (BHP01): the first dose was 5x10\\^5\u002Fkg.",[9],[21],"Bridge radiotherapy",[23],{"name":24,"affiliation":25,"role":26},"You Lu, MD","West China Hospital","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Jianxin Xue, MD","CONTACT","18982251798",null,"killercell@163.com",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Zhuoran Yao, MD","13261660839","yaozhuoran@outlook.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"West China Hospital Sichuan University","RECRUITING","Chengdu","Sichuan","610041","China",{"type":47,"coordinates":48},"Point",[49,50],104.06667,30.66667,{"lat":50,"lon":49},[53],{"name":54,"role":30,"phone":55,"phoneExt":32,"email":56},"Li Li","+086-02885424619","tracy.li_2010@hotmail.com",{"type":26,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"You Lu","Chair of Department of Thoracic Cancer",[61],{"name":62,"class":63},"Chengdu Brilliant Pharmaceutical Co., Ltd.","INDUSTRY","100542894",false,"NCT06348797","Phase I Clinical Study of α-PD-L1\u002FDLL3 CAR-T in Patients With R\u002FR SCLC","Phase I Clinical Study on Safety and Feasibility of DLL3 Targeted α-PD-L1\u002F4-1BB Modifying Chimeric Antigen Receptor T-cells in Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n* Patients with recurrent or refractory small cell lung cancer (SCLC) confirmed by histology or cytology who have relapsed or progressed after treatment with one previous platinum-based regimen;\n* Patients can provide sufficient tumor tissue (fresh or paraffin sections, etc.);\n* Age 18 \\~70 (including boundary), for both men and women;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n* Life expectancy ≥3 months;\n* At least one extracranial measurable lesion (RECIST v1.1) exists；for lesion after radiotherapy， must be confirmed that the lesion has progressed ;\n* Patients in limited-stage at the initial diagnosis must undergo radical thoracic radiotherapy and the time of tumor progression is not less than 3 months from the end of radiotherapy, or radical thoracic dose radiotherapy cannot be performed for specific reasons;\n* The test results of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C and syphilis were negative at screening;\n* Female patients or male reproductive age patients and their partners should agree to effective contraception from sighing Informed Consent Form (ICF) to 6 months after the last BHP01 infusion.\n\nExclusion Criteria:\n\n* Patients with known primary Central Nervous System (CNS) tumor, or meningeal metastasis, or patients with unstable CNS metastasis (symptomatic, requiring hormonal therapy within 4 weeks before investigational treatment, or no radiographic evidence of stabilization of the lesion for more than 4 weeks);\n* Received major surgical procedures （except for diagnosis） within 4 weeks before PBMCs collection, or are expected to require major surgical procedures during the study;\n* Received Chinese herbal medicine or Chinese patent medicine for anti-tumor indications within 7 days before Peripheral Blood Mononuclear Cells (PBMCs) collection;\n* Patients with a history of idiopathic pulmonary fibrosis, mechanical pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia by chest computer tomography (CT) at screening \\[a history of radiation pneumonia (fibrosis) in the irradiated field may participate in this study\\];\n* Poorly controlled pleural effusion, pericardial effusion, or ascites requiring repeated drainage procedures (once a month or more frequently);\n* Poorly controlled or symptomatic hypercalcemia (ionic calcium\\> 1.5 mmol\u002FL, calcium\\> 12 mg\u002FdL or corrected calcium\\> ULN);\n* Presence of active or previous autoimmune diseases or immunodeficiencies, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, etc.;\n* Severe infection within 4 weeks before the start of PBMCs collection, including but not limited to hospitalization due to infection, bacteremia, severe pneumonia, or any active infection that may affect the patient's safety;\n* Serious cardiovascular and cerebrovascular diseases (such as heart disease ≥New York Heart Association class II, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable angina pectoris within 3 months before PBMCs collection;\n* Previous treatment with DLL 3 target drugs or CAR-T or other gene-modified T cells;\n* Received any other Investigational drug within 28 days prior to PBMCs collection;\n* A history of mental illness;\n* Incapacitated persons or persons with limited capacity;\n* pregnant or lactating females; Males or females who are unwilling to use adequate contraception; Females of childbearing potential are required to undergo a pregnancy study during the screening period;","ALL","18 Years","70 Years",{"count":74,"type":75},28,"ESTIMATED","INTERVENTIONAL",[78],"PHASE1","A study to evaluate the safety and feasibility of α-PD-L1\u002F4-1BB DLL3 Chimeric Antigen Receptor (CAR)-T (BHP01) in patients with Relapsed\u002FRefractory Small Cell Lung Cancer (SCLC) and determine the appropriate CAR-T cell dose. Next, In dose expansion phase, patients were assign two groups with\u002Fwithout bridge radiotherapy.",[81],"Small Cell Lung Cancer Extensive Stage",[83,84,85],"Extensive Stage-SCLC","DLL3 CAR-T","Bridge Radiotherapy","2025-05-13",{"date":88,"type":89},"2025-05-16","ACTUAL",{"date":91,"type":89},"2025-04-03",{"date":93,"type":75},"2026-12-31",{"name":5,"class":6},1]