[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629822":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":38,"collaborators":11,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":11,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"Shanghai Cell Therapy Group Co.,Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Armored Dendritic Cell Injection","EXPERIMENTAL",null,[13],"Biological: Armored Dendritic Cell Injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"BIOLOGICAL","Armored dendritic cells are administered via multiple subcutaneous injections.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Xu Qing","CONTACT","13761325567","xuqing@shcell.com",[26],{"facility":27,"status":28,"city":29,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":11},"Shanghai Mengchao Tumor Hospital","RECRUITING","Shanghai","China","CN",{"type":33,"coordinates":34},"Point",[35,36],121.45806,31.22222,{"lat":36,"lon":35},{"type":39,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100629822","phase-1-an-antibody-armored-dendritic-cell-in-patients-with-solid-tumors-100629822",false,"NCT07479667","An Antibody-armored Dendritic Cell in Patients With Solid Tumors","An Exploratory, Single-arm, Open-label Study to Evaluate the Safety and Tolerability of Antibody-armored Dendritic Cell Injection Following a Single Administration in Patients With Solid Tumors","dendritic cell","Inclusion Criteria:\n\n* Aged 18 to 80 years, body weight ≥ 40 kg; male or female, no gender restriction;\n* ECOG performance status score of 0 to 1;\n* Histopathologically confirmed solid tumors including pancreatic cancer, colorectal cancer (CRC), gastric cancer and other such malignancies;\n* Having undergone R0 or R1 resection with completion of at least 4 cycles of standard postoperative adjuvant chemotherapy;\n* Positive expression for at least one of TERT, P53, KRAS and Survivin;\n* Sufficient venous access with no contraindications to peripheral blood mononuclear cell collection;\n* Adequate organ and bone marrow function:\n* a) Platelet count ≥ 90×10⁹\u002FL;\n* b) Hemoglobin ≥ 90 g\u002FL (no blood transfusion or erythropoietin dependence within 7 days);\n* c) Mononuclear cell count ≥ 1.0×10⁹\u002FL;\n* d) International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × upper limit of normal (ULN);\n* e) Serum creatinine ≤ 1.5 × upper limit of normal (ULN);\n* f) Aminotransferases (AST, ALT) ≤ 2.5 × upper limit of normal (ULN);\n* g) Total bilirubin ≤ 2 × upper limit of normal (ULN);\n* h) Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as assessed by echocardiography within 1 month prior to enrollment;\n* Able to understand the study requirements and considerations and provide informed consent to participate in the clinical study in accordance with the study requirements\n* Subjects agree to use effective contraceptive measures for at least 6 months following dendritic cell (DC) injection.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding;\n* Positive for human immunodeficiency virus (HIV) antibody or syphilis antibody; positive for hepatitis B surface antigen (HBsAg), positive for hepatitis B core antibody (anti-HBc) or hepatitis B e antibody (anti-HBe) with hepatitis B virus (HBV) DNA copy number above the lower limit of detection (LLOD) or ≥ 1000 copies\u002FmL; or hepatitis C virus (HCV) RNA copy number above the LLOD;\n* Prior treatment with any dendritic cell (DC) or other immune cell therapy;\n* History of hypersensitivity to immunotherapy and related drugs, or history of severe allergic reactions;\n* Uncontrolled active infection;\n* Subjects with active autoimmune disease receiving relevant treatment; subjects with organ transplantation who are still on immunosuppressive agents; or subjects requiring long-term use of immunosuppressive agents (\\> 15 mg\u002Fday prednisone or equivalent glucocorticoid dose) and who have used them within 4 weeks prior to screening;\n* Presence of central nervous system (CNS) metastases and clinically significant CNS diseases;\n* Received systemic anti-tumor therapy within 4 weeks prior to screening;\n* Presence of residual lesions or unremoved foci on screening examinations (post-adjuvant chemotherapy \u002F post-surgery), with imaging indicating local recurrence or confirmed distant metastasis;\n* History of other active malignancies within 5 years (excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, etc.);\n* Clinically significant major cardiovascular diseases including:\n* a) Symptomatic congestive heart failure\n* b) Unstable angina pectoris\n* c) Severe arrhythmia requiring pharmacotherapy\n* d) Uncontrolled hypertension\n* e) Myocardial infarction or ventricular arrhythmia within 6 months prior to screening;\n* Any other conditions deemed by the investigator to render the subject ineligible for participation in the clinical study","ALL","18 Years","80 Years",{"count":52,"type":53},8,"ESTIMATED","INTERVENTIONAL",[56],"PHASE1","This study is a single-arm, open-label, single-administration dose-escalation study.",[59,60],"Solid Cancers","Adjuvant Therapy","2026-03-15",{"date":63,"type":64},"2026-03-18","ACTUAL",{"date":66,"type":64},"2026-02-05",{"date":68,"type":53},"2029-06-30",{"name":5,"class":6},1]