[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607167":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":27,"interventions":33,"overallOfficials":20,"centralContacts":38,"locations":44,"responsibleParty":59,"collaborators":61,"id":65,"slug":20,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":20,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":20,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":20,"overallStatus":46,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of all adverse events occurring within 28 days after the first infusion of KN5001","To characterize the Treatment Emergent Adverse Events (TEAEs) of KN5001 for patients with pulmonary nodules","Time Frame: up to 28 days after infusion",[14,18],{"measure":15,"description":16,"timeFrame":17},"The overall response rate (ORR)","To characterize the efficacy of KN5001 for patients with pulmonary nodules","Time Frame: 6 and 12 months after infusion",{"measure":19,"description":16,"timeFrame":17},"Disease control rate (DCR)",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"NA","SINGLE_GROUP","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE",[28],{"label":29,"type":30,"description":20,"interventionNames":31},"KN5001","EXPERIMENTAL",[32],"Biological: KN5001",[34],{"type":35,"name":29,"description":36,"armGroupLabels":37,"otherNames":20},"BIOLOGICAL","Subjects will receive KN5001 on day0, 3, and 6. Multiple Doses of KN5001 will infused using the \"3 + 3\" dose-escalation strategy.",[29],[39],{"name":40,"role":41,"phone":42,"phoneExt":20,"email":43},"Yongqian Shu","CONTACT","086-13951017570","shuyongqian@csco.org.cn",[45],{"facility":5,"status":46,"city":47,"state":20,"zip":20,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Nanjing","China","CN",{"type":51,"coordinates":52},"Point",[53,54],118.77778,32.06167,{"lat":54,"lon":53},[57],{"name":58,"role":41,"phone":20,"phoneExt":20,"email":20},"yongqian Shu, Dr",{"type":60,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[62],{"name":63,"class":64},"Rui Therapeutics Co., Ltd","INDUSTRY","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":74,"type":75},24,"ESTIMATED","INTERVENTIONAL",[78],"EARLY_PHASE1","A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules.",[81,82],"Pulmonary Nodules, Solitary","Pulmonary Nodules, Multiple","2025-11-24",{"date":85,"type":86},"2025-12-01","ACTUAL",{"date":88,"type":86},"2025-09-20",{"date":90,"type":75},"2027-09-20",{"name":5,"class":6},1]