[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607167":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":40,"collaborators":42,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":11,"eligibilityCriteria":51,"healthyVolunteers":48,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":11,"overallStatus":27,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"KN5001","EXPERIMENTAL",null,[13],"Biological: KN5001",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"BIOLOGICAL","Subjects will receive KN5001 on day0, 3, and 6. Multiple Doses of KN5001 will infused using the \"3 + 3\" dose-escalation strategy.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Yongqian Shu","CONTACT","086-13951017570","shuyongqian@csco.org.cn",[26],{"facility":5,"status":27,"city":28,"state":11,"zip":11,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"RECRUITING","Nanjing","China","CN",{"type":32,"coordinates":33},"Point",[34,35],118.77778,32.06167,{"lat":35,"lon":34},[38],{"name":39,"role":22,"phone":11,"phoneExt":11,"email":11},"yongqian Shu, Dr",{"type":41,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[43],{"name":44,"class":45},"Rui Therapeutics Co., Ltd","INDUSTRY","100607167","early-phase-1-an-exploratory-clinical-study-on-the-safety-and-efficacy-of-autologous-nk-cells-in-the-treatment-of-pulmonary-nodules-100607167",false,"NCT07185035","An Exploratory Clinical Study on the Safety and Efficacy of Autologous NK Cells in the Treatment of Pulmonary Nodules","Inclusion Criteria:\n\n1. Subjects voluntarily sign the informed consent form, understand this clinical study, and are willing to follow and able to complete all trial procedures;\n2. 18-70 years old, male or female;\n3. Subjects with lung nodules confirmed by imaging examination must meet the following conditions:\n\n   Multiple high-risk nodules have been surgically removed and confirmed to be malignant lesions, and the remaining high-risk nodules (refer to the standards in Appendix 12) cannot be surgically removed again, and are not suitable for other effective treatments or have failed other treatments;\n4. If the subject is unable to complete the puncture or the puncture fails, the subject must be diagnosed as a malignant nodule through PET-CT imaging examination.\n\nExclusion Criteria:\n\n1. Subjects who are known to have allergic reactions, hypersensitivity reactions, intolerances or contraindications to any component of KN5001, or subjects with a history of severe allergic reactions;\n2. Subjects with the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any known bone marrow failure syndrome;\n3. Subjects with active or uncontrolled infections requiring parenteral antibiotics; Evidence of a serious active viral or bacterial infection or an uncontrolled systemic fungal infection;\n4. Subjects with heart failure of grade III or IV according to the New York Heart Association (NYHA) cardiac function classification standard (see Appendix 1);\n5. Subjects with a history of epilepsy or other central nervous system diseases;\n6. Subjects with a history of malignant tumors, excluding patients with cured skin or cervical carcinoma in situ and patients with inactive tumors;\n7. Subjects with a significant bleeding tendency, such as gastrointestinal bleeding, coagulopathy, hypersplenism, etc.;\n8. Subjects with unstable angina, symptomatic congestive heart failure, or myocardial infarction in the past 6 months;\n9. Females who are pregnant, lactating, or planning a pregnancy within six months;\n10. Subjects who have received other clinical trial treatment within 3 months;\n11. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.","ALL","18 Years","70 Years",{"count":56,"type":57},24,"ESTIMATED","INTERVENTIONAL",[60],"EARLY_PHASE1","A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules.",[63,64],"Pulmonary Nodules, Solitary","Pulmonary Nodules, Multiple","2025-11-24",{"date":67,"type":68},"2025-12-01","ACTUAL",{"date":70,"type":68},"2025-09-20",{"date":72,"type":57},"2027-09-20",{"name":5,"class":6},1]