[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Celconta Life Science Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"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":20,"type":21},115,"ESTIMATED","INTERVENTIONAL",[24],"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",[27],"Stage IIIA Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2025-06-29",{"date":31,"type":32},"2025-07-01","ACTUAL",{"date":34,"type":21},"2025-07-08",{"date":36,"type":21},"2029-06-18",{"name":38,"class":39},"Shenzhen Celconta Life Science Co., Ltd.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100585043","phase-1-pank-003-cell-injection-combined-with-standard-adjuvant-chemotherapy-after-surgery-in-patients-with-solid-tumors-100585043","NCT06897228","PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Solid Tumors","A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial on the Safety and Efficacy of PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Solid Tumors","Inclusion Criteria:\n\n1. Understand and voluntarily 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 who have been histologically confirmed or diagnosed by imaging (computed tomography (CT) examination, magnetic resonance imaging (MRI) examination or positron emission tomography (PET) scan CT (PET\u002FCT)) as postoperative patients with malignant solid tumors;\n4. Patients who have undergone surgical treatment and are going to receive or are currently undergoing postoperative adjuvant chemotherapy;\n5. At the time of enrollment, the expected survival time is more than 6 months;\n6. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;\n7. 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× the upper limit of normal value (ULN). For patients with a history of Gilbert's syndrome\u002Fsuspected of having the disease, the total bilirubin (TBIL) should 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)\\]);\n8. Good lung function, with a baseline fingertip pulse oximetry saturation ≥ 95% in an indoor air environment;\n9. Female subjects of childbearing age must undergo a serum pregnancy test at the time of screening with a negative result, and be willing to use a medically approved highly effective contraceptive method during the study period and for at least 1 year after the last study treatment. For male subjects whose partners are of childbearing age, they should have undergone surgical sterilization or agree to use an effective contraceptive method during the study period and for at least 1 year after the last study treatment;\n10. Be evaluated by the investigator as suitable for inclusion in this clinical study.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Individuals with a history of allergy to any component of the cell product;\n3. Patients with other malignant tumors, except for the following situations: cured non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 5 years;\n4. Positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg), positive for hepatitis B e antibody (HBe-Ab) and\u002For hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is greater than the lower limit of measurability; positive for hepatitis C antibody (HCV-Ab); positive for Treponema pallidum antibody (TP-Ab); positive for human immunodeficiency virus (HIV) antibody test; anyone meeting any one of these items;\n5. Patients who have received drugs from other clinical trials or other cellular immunotherapies within 28 days before the screening period;\n6. Those who have received live vaccines or live attenuated vaccines within 4 weeks before NK cell infusion;\n7. Patients with comorbidities that, in the judgment of the investigator, require treatment with systemic corticosteroids or other immunosuppressive drugs during the study period;\n8. Individuals with a high allergic constitution, those allergic to any component of the NK preparation product, including those allergic to serum albumin; those allergic to commonly used emergency and anesthetic drugs;\n9. Having any unstable circulatory system diseases within 180 days before screening, including but not limited to unstable angina pectoris, myocardial infarction, heart failure \\[New York Heart Association (NYHA) class ≥ III\\], severe arrhythmia requiring drug treatment, or having undergone angioplasty, coronary artery stent implantation, or coronary artery bypass grafting within 180 days before screening;\n10. Diseases or other situations that the investigator deems unsuitable for this clinical study (such as high allergic constitution, poorly controlled diabetes mellitus, uncontrolled infections, presence of central nervous system diseases, bleeding and thrombotic tendencies; as well as poor compliance, drug abuse, etc.).",{"count":48,"type":21},18,[50],"PHASE1","A single-center, single-arm, dose-escalation exploratory clinical trial on the safety and efficacy of PANK-003 cell injection(Peripheral blood-derived allogeneic natural killer cells )combined with standard adjuvant chemotherapy after surgery in patients with solid tumors",[53],"Solid Tumors, Adult","RECRUITING","2025-03-20",{"date":57,"type":32},"2025-03-26",{"date":59,"type":32},"2024-02-18",{"date":61,"type":21},"2027-03",{"name":38,"class":39},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":63},"100576217","phase-1-treating-claudin182-positive-advanced-solid-tumors-with-xkdct225targeting-claudin182-car-t-100576217","NCT06782425","Treating Claudin18.2-positive Advanced Solid Tumors with XKDCT225(Targeting Claudin18.2-CAR-T)","A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial of the Safety, Efficacy, and Pharmacokinetics of XKDCT225 (Targeting Claudin18.2-CAR-T) Cell Injectionin Claudin18.2-positive Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age 18-75 (including the critical value), regardless of gender;\n2. Patients with advanced solid tumors (including but not limited to gastric adenocarcinoma, esophagogastric junction adenocarcinoma, esophageal adenocarcinoma) with moderate to high expression of Claudin18.2 (expression intensity ≥ 2+ and tumor cell positive rate ≥ 50 %), and whose condition cannot be completely relieved or continues to progress after adequate treatment;\n3. At least one measurable lesion according to RECIST 1.1 criteria (non-lymph node lesion with long diameter ≥10 mm, lymph node lesion with short diameter ≥15 mm);\n4. Estimated life expectancy \\> 12 weeks;\n5. ECOG physical status score 0 \\~ 1;\n6. Laboratory test values for screening must meet the following criteria:\n\nRoutine blood test:\n\n* WBC≥3.0×10\\^9 \u002FL\n* ANC≥1.5×10\\^9 \u002FL\n* LYMPH≥0.5×10\\^9 \u002FL\n* HB≥90g\u002FL\n* PLT≥75×10\\^9 \u002FL\n\nBlood biochemistry examination:\n\n* ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN if liver metastasis is present)\n* ALB≥30g\u002FL\n* Serum creatinine ≤1.5×ULN or GFR\\>50mL\u002Fmin (GFR = \\[(140-age)×weight×(0.85female)\\]\u002F(72×Scr))\n* TBIL≤1.5×ULN\n\nCoagulation function test:\n\n* APTT ≤ 1.5 ULN, with INR or PT ≤ 1.5 ULN (not receiving anticoagulation therapy) 7. Female subjects of childbearing age must undergo a serum pregnancy study with negative results at screening and before purging, and be willing to use medically approved highly effective contraceptive methods during the study and for at least 1 year after the last study treatment. Male subjects whose partners are female subjects of childbearing age should undergo surgical sterilization or agree to use effective contraceptive methods during the study and for at least 1 year after the last study treatment, and are prohibited from donating sperm within 1 year.\n\n  8\\. If the patient is using the following medications, the corresponding conditions must be met:\n* Steroids: Therapeutic doses of steroids must be discontinued 4 weeks prior to XKDCT 225 cell injection. However, physiological replacement doses of steroids are allowed: hydrocortisone or equivalent \\\u003C6\\~ 12mg \u002F mm\\^2 \u002F day ;\n* Immunosuppression: Any immunosuppressive drugs must be stopped ≥ 4 weeks before enrollment; 9. Volunteer to participate in the clinical trial and sign the informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women;\n2. Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive, and HBV DNA copy number positive; Hepatitis C antibody (HCV-Ab) positive; Anti-Treponema pallidum antibody (TP-Ab) positive; Human immunodeficiency virus antibody (HIV-Ab) positive; Those who meet any of the following conditions;\n3. Any active infection requiring antibiotic treatment;\n4. Received any immune cell therapy within one year;\n5. Previously received Claudin18.2 targeted therapy ;\n6. Live vaccine or live attenuated vaccine received within 4 weeks before single collection;\n7. Surgery has been performed within 2 weeks before apheresis and the researchers believe that it may affect the patient's safety;\n8. Active coronary heart disease (including angina pectoris, myocardial infarction) within 6 months before enrollment;\n9. Within 6 months before study entry, the subject had a history of clinically significant arrhythmias or current abnormalities requiring antiarrhythmic treatment other than beta-blockers or digoxin and\u002For conduction drugs, excluding atrial fibrillation and paroxysmal supraventricular tachycardia;\n10. Left ventricular ejection fraction (LVEF) \\\u003C50% or congestive heart failure (New York Heart Association NYHA classification ≥3) at screening;\n11. Uncontrolled diabetes (glycosylated hemoglobin\\>8%), uncontrolled hypertension (systolic blood pressure\u002Fdiastolic blood pressure\\>160mmHg\u002F100mmHg while taking medication);\n12. Patients with active autoimmune diseases within 3 months before screening, such as systemic lupus erythematosus, who need to continue taking medication during the entire trial period;\n13. Other malignancies occurred within 5 years before enrollment, excluding cervical carcinoma in situ, skin squamous cell carcinoma, or basal cell carcinoma that had been treated with radical cure;\n14. Have a known symptomatic central nervous system (CNS) disease;\n15. Tumor cells infiltrate the central nervous system, and tumor cells are detected in the cerebrospinal fluid or the tumor is detected by cranial imaging;\n16. The tumor has extensive metastasis and involves more than two organs at the same time, which the investigator believes may significantly change the baseline assessment; or the tumor has progressed rapidly and has reached PD between enrollment and lymph node clearance;\n17. Difficult airway (tumor growth blocking the airway or airway deformity, etc.);\n18. before apheresis, lymph node ablation, and XKDCT 225 cell injection to maintain fingertip blood oxygen saturation \\> 95%;\n19. The subject has unstable or active gastric ulcer or active gastrointestinal bleeding, or other conditions that may require emergency treatment during the trial, including but not limited to gastrointestinal obstruction, perforation, and rupture of giant tumors;\n20. Patients with pleural and abdominal effusion greater than grade 2 during screening and unable to be controlled by drainage or diuretics;\n21. The subject is currently taking anticoagulants and cannot stop taking them during the entire trial;\n22. Allergy or intolerance to the research drugs tocilizumab, fludarabine, cyclophosphamide and other lymphoproliferative drugs selected by the investigator;\n23. Those who are allergic to common emergency and anesthetic drugs, and have life-threatening allergic reactions, hypersensitivity reactions, or intolerance to XKDCT 225 cell preparations or their components; Patients who were deemed unsuitable for participation in this study by the investigator.",{"count":48,"type":21},[50],"A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT225 cell injection in Claudin18.2-positive advanced solid tumors",[75],"Claudin18.2 Positive Advanced Solid Tumors","2025-01-14",{"date":78,"type":32},"2025-01-17",{"date":80,"type":21},"2025-01",{"date":82,"type":21},"2028-01",{"name":38,"class":39},""]