[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523612":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":49,"centralContacts":54,"locations":64,"responsibleParty":80,"collaborators":82,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":38,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":38,"enrollmentInfo":95,"targetDuration":38,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":67,"whyStopped":38,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Base Therapeutics (Shanghai) Co., Ltd.","INDUSTRY",[8,15,19,23,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A (low-dose group)","EXPERIMENTAL","NK510 will be administered once a week for a total of six weeks.3×10\\^9 NK cells\u002Fdose.\n\nPD-1 blockade will be administered every 1 or 3 weeks, depending on PD-1 blockade chosed by investigator.",[13,14],"Drug: NK510","Drug: Tislelizumab，atezolizumab or sugemalimab",{"label":16,"type":10,"description":17,"interventionNames":18},"Group B (medium-dose group)","NK510 will be administered once a week for a total of six weeks.9×10\\^9 NK cells\u002Fdose.\n\nPD-1 blockade will be administered every 1 or 3 weeks, depending on PD-1 blockade chosed by investigator..",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Group C (high-dose group)","NK510 will be administered once a week for a total of six weeks.12×10\\^9 NK cells\u002Fdose.\n\nPD-1 blockade will be administered every 1 or 3 weeks, depending on PD-1 blockade chosed by investigator..",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Group D1 (low-dose group)","Thoracic perfusion therapy will be conducted on Day 1 (D1) and Day 5 (D5) of each 3-week treatment cycle, with 3×10⁹ NK510 cells\u002Fdose for each time via intrapleural infusion, for 2 consecutive cycles.",[13,27],"Drug: systemic therapy as selected by the investigator",{"label":29,"type":10,"description":30,"interventionNames":31},"Group D2 (high-dose group)","Thoracic perfusion therapy will be administered on Day 1 (D1) and Day 5 (D5) of each 3-week treatment cycle, with 6×10⁹ NK510 cells\u002Fdose for each time via intrapleural infusionwith, for 2 consecutive cycles.",[13,27],[33,39,43,46],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","NK510","Intravenous infusion",[9,16,20],null,{"type":34,"name":40,"description":41,"armGroupLabels":42,"otherNames":38},"Tislelizumab，atezolizumab or sugemalimab","Administer according to the instructions",[9,16,20],{"type":34,"name":35,"description":44,"armGroupLabels":45,"otherNames":38},"intrapleural infusion",[24,29],{"type":34,"name":47,"description":41,"armGroupLabels":48,"otherNames":38},"systemic therapy as selected by the investigator",[24,29],[50],{"name":51,"affiliation":52,"role":53},"Tangfeng Lv, PhD","Jinling hospital, Nanjing, China","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":38,"email":59},"Jun Yan, PhD","CONTACT","+86 186 2166 8515","yanjun@basetherapeutics.com",{"name":61,"role":57,"phone":62,"phoneExt":38,"email":63},"Tangfeng Lv","+86 139 5201 6932","bairoushui@163.com",[65],{"facility":66,"status":67,"city":68,"state":69,"zip":38,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Jinling hospital, affiliated to Medical school Nanjing University","RECRUITING","Nanjing","Jiangsu","China","CN",{"type":73,"coordinates":74},"Point",[75,76],118.77778,32.06167,{"lat":76,"lon":75},[79],{"name":61,"role":57,"phone":62,"phoneExt":38,"email":63},{"type":81,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[83],{"name":84,"class":85},"Jinling Hospital, China","OTHER","100523612","early-phase-1-safety-and-efficacy-of-nk510-to-treat-nsclc-100523612",false,"NCT06097962","Safety and Efficacy of NK510 to Treat NSCLC","First-in-Human Phase I Study of TIGIT-Blocked NK510 Cells in Patients With PD-1 Refractory Advanced NSCLC","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female.\n* For dose expansion group (Group A\u002FB\u002FC):\n\nA. EGFR mutation-negative, ROS1-negative, and ALK-negative; unresectable and non-radiotherapeutic stage III or IV, locally advanced, recurrent or metastatic NSCLC.\n\nB. Disease progression after ≥4 courses of PD-(L)1 blockade ± chemotherapy.\n\n* For pleural perfusion group (Group D1\u002FD2): Advanced NSCLC with malignant pleural effusion ≥500ml (confirmed by B-ultrasound or CT); patients with driver gene-positive and resistant to targeted therapy are acceptable.\n* At least one CT or MRI measurable lesion according to RECIST v1.1.\n* ECOG performance status 0-2.\n* Expected survival ≥3 months.\n* All toxicities from previous anti-tumor therapy (except alopecia and fatigue) resolved to grade 1 (CTCAE v5.0) or baseline; subjects with long-term sequelae from previous therapy (e.g., neuropathy after platinum-based therapy) are acceptable.\n* Fertile females must be non-lactating and have a negative serum pregnancy test within 1 week before enrollment; all subjects (male or female) must agree to use contraception from signing informed consent until 6 months after the last NK510 infusion.\n* Able to comply with the study protocol and follow-up procedures.\n* Voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Symptomatic central nervous system (CNS) metastasis and\u002For carcinomatous meningitis.\n* Active, known or suspected autoimmune diseases (excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic treatment \\[e.g., vitiligo, psoriasis, alopecia\\] or diseases not expected to recur without external triggers).\n* History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormalities requiring clinical intervention (e.g., ventricular arrhythmia, grade III atrioventricular block); QTc interval \\>480 ms on 12-lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade ≥3 cardiovascular and cerebrovascular events within 6 months before enrollment; NYHA cardiac function class ≥II or left ventricular ejection fraction (LVEF) \\\u003C50%; clinically uncontrolled hypertension.\n* Blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor treatment within 2 weeks before enrollment.\n* Systemic treatment with corticosteroids (prednisone \\>10 mg\u002Fday or equivalent) or other immunosuppressive\u002Fimmunomodulatory drugs (e.g., thymosin, interleukin-2, interferon) within 2 weeks before enrollment; inhalation or topical corticosteroids are allowed in subjects without active autoimmune diseases.\n* Known allergy or intolerance to PD-(L)1 blockade.\n* Meeting any of the following laboratory criteria:\n\n  1. Hematology: Neutrophils \\\u003C1.5×10⁹\u002FL; Platelets \\\u003C75×10⁹\u002FL; Hemoglobin \\\u003C90 g\u002FL.\n  2. Liver function: ALT \\>3×ULN (≥5×ULN in patients with liver metastasis); AST \\>3×ULN (≥5×ULN in patients with liver metastasis); TBIL \\>1.5×ULN or \\>2.5×ULN (3.0 mg\u002FdL) in patients with Gilbert syndrome.\n  3. Renal function: Serum creatinine \\>1.5×ULN or creatinine clearance \\\u003C50 mL\u002Fmin.\n* Any other severe or uncontrollable medical diseases, active infections, physical examination abnormalities, laboratory test abnormalities, mental status changes or mental illnesses that increase subject risk or affect study results (assessed by investigator).","ALL","18 Years",{"count":96,"type":97},12,"ESTIMATED","INTERVENTIONAL",[100],"EARLY_PHASE1","This study assesses the safety and efficacy of NK510 combined with PD-(L)1 inhibitors for relapsed\u002Frefractory advanced NSCLC, with two administration routes: intravenous infusion and intrapleural perfusion for malignant pleural effusion. Eligible patients need confirmed measurable lesions; intravenous cohort requires EGFR\u002FROS1\u002FALK negativity and disease progression after PD-(L)1 inhibitor treatment, while intrapleural cohort accepts targeted therapy-resistant patients with ≥500ml pleural effusion, and the treatment's safety, efficacy and immune microenvironment changes will be evaluated.",[103],"NSCLC",[105],"Malignant Pleural Effusion","2026-05-18",{"date":108,"type":109},"2026-05-20","ACTUAL",{"date":111,"type":109},"2023-07-01",{"date":113,"type":97},"2026-07-01",{"name":5,"class":6},1]