[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596319":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":18,"locations":11,"responsibleParty":24,"collaborators":11,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":11,"eligibilityCriteria":32,"healthyVolunteers":28,"sex":33,"minAge":34,"maxAge":35,"enrollmentInfo":36,"targetDuration":11,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":11,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":11},{"fullName":5,"class":6},"Shenzhen Celconta Life Science Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy","EXPERIMENTAL",null,[13],"Drug: PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy",[15],{"type":16,"name":9,"description":9,"armGroupLabels":17,"otherNames":11},"DRUG",[9],[19],{"name":20,"role":21,"phone":22,"phoneExt":11,"email":23},"Shuanghu Yuan","CONTACT","0551-65897870","yuanshuanghu@sina.com",{"type":25,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100596319","phase-2-pank-003-cell-injection-combined-with-standard-adjuvant-chemotherapy-after-surgery-in-patients-with-stage-iiia-nsclc-100596319",false,"NCT07043907","PANK-003 Cell Injection Combined With Standard Adjuvant Chemotherapy After Surgery in Patients With Stage IIIA NSCLC","A Single-center, Single-arm Exploratory Clinical Trial on the Safety and Efficacy of PANK-003 Cell Injection Combined With Standard Adjuvant Chemotherapy After Surgery in Patients With Stage IIIA Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily participate in the clinical trial; fully understand and be informed about this study and sign the informed consent form;\n2. At the time of screening, the age should be between 18 and 75 years old (inclusive), regardless of gender;\n3. Patients with histologically confirmed stage IIIA NSCLC (T4N0M0, T3-4N1M0, T1a-2bN2M0) who underwent R0 resection and received postoperative adjuvant chemotherapy (Exclusion of EGFR sensitizing mutations and ALK fusion); and who received the first dose of PANK-003 cell injection combined with postoperative adjuvant chemotherapy within 8 weeks after radical surgery.;\n4. At the time of enrollment, the expected survival time is more than 6 Months;\n5. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;\n6. At the time of screening, the laboratory tests should meet the following requirements:\n\n   * White blood cell count ≥ 3.0×10⁹\u002FL;\n   * Neutrophil count ≥ 1.5×10⁹\u002FL;\n   * Lymphocyte count ≥ 0.5×10⁹\u002FL;\n   * Hemoglobin ≥ 90 g\u002FL;\n   * Platelets ≥ 75×10⁹\u002FL;\n   * Serum total bilirubin ≤ 2.0 × ULN (Upper Limit of Normal); for patients with a history\u002Fsuspected Gilbert's syndrome, total bilirubin (TBIL) must be ≤ 3 × ULN.\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN;\n   * Creatinine \\\u003C 1.5×ULN and endogenous creatinine clearance rate ≥ 50 mL\u002Fminute (Cockcroft-Gault method for calculating creatinine clearance rate: For men, creatinine clearance rate = \\[(140 - age) × body weight (kg)\\] \u002F \\[0.818 × creatinine (μmol\u002FL)\\]; For women, creatinine clearance rate = \\[(140 - age) × body weight (kg) × 0.85\\] \u002F \\[0.818 × creatinine (μmol\u002FL)\\]).\n7. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and be willing to use medically recognized highly effective contraception during the study and for at least 1 year after the last study treatment; male subjects with partners of childbearing potential must have undergone surgical sterilization or agree to use effective contraception during the study and for at least 1 year after the last study treatment;\n8. Investigator-confirmed eligibility for study enrollment.\n\nExclusion Criteria:\n\n1. NSCLC patients who have received neoadjuvant therapy;\n2. Pregnant or lactating women;\n3. History of other malignancies, except:\n\n   * Cured non-melanoma skin cancer\n   * Carcinoma in situ of the cervix\n   * Localized prostate cancer\n   * Superficial bladder cancer\n   * Other malignancies with disease-free survival \\>5 years;\n4. Positive virology serology meeting any of:\n\n   * HBsAg(+) and\u002For HBeAg(+) with HBe-Ab(+) and\u002For HBc-Ab(+) and HBV-DNA \\> lower limit of quantification\n   * HCV-Ab(+)\n   * TP-Ab(+)\n   * HIV-Ab(+);\n5. Received investigational drugs or other cell-based immunotherapy within 28 days before screening;\n6. Administration of live\u002Fattenuated vaccines within 4 weeks prior to NK cell infusion;\n7. Medical conditions requiring systemic corticosteroid therapy or other immunosuppressive drug treatments during the study period as determined by the investigator;\n8. Hypersensitivity to:\n\n   * Any component of NK cell products (including serum albumin)\n   * Common emergency medications or anesthetics;\n9. Unstable cardiovascular diseases within 180 days pre-screening, including:\n\n   * Unstable angina\n   * Myocardial infarction\n   * Heart failure (NYHA class ≥III)\n   * Severe arrhythmia requiring medication\n   * Cardiac angioplasty, coronary stenting, or CABG;\n10. Any condition that may compromise protocol compliance or patient safety as determined by the investigator:\n\n    * Poorly controlled diabetes\n    * Uncontrolled infections\n    * Central nervous system disorders\n    * Bleeding\u002Fthrombotic diathesis\n    * Poor compliance\n    * Substance abuse.","ALL","18 Years","75 Years",{"count":37,"type":38},115,"ESTIMATED","INTERVENTIONAL",[41],"PHASE2","A Single-center, Single-arm Clinical Trial on the Safety and Efficacy of PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Stage IIIA Non-Small Cell Lung Cancer",[44],"Stage IIIA Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2025-06-29",{"date":48,"type":49},"2025-07-01","ACTUAL",{"date":51,"type":38},"2025-07-08",{"date":53,"type":38},"2029-06-18",{"name":5,"class":6}]