[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579140":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":31,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":20,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Anti-CDH17 CAR-T cells","EXPERIMENTAL","CDH17 CAR-T is a novel CAR cell therapy for the treatment of advanced solid tumors.",[13],"Biological: Anti-CDH17 CAR-T cells infusion",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Anti-CDH17 CAR-T cells infusion","Subiects who meet the enrollment conditions will receive intravenous infusion of anti-CDH17 CAR-T Cells after lymphodepleting therapy.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Sanbin Wang, MD","Principal Investigator Sanbin Wang 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","13187424131","Sanbin1011@163.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Sanbin Wang","RECRUITING","Kunming","Yunnan","650100","China","CN",{"type":41,"coordinates":42},"Point",[43,44],102.71833,25.03889,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":29,"phoneExt":20,"email":30},"Sanbin Wang Wang, MD",{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[52],{"name":53,"class":54},"Guangzhou Bio-gene Technology Co., Ltd","INDUSTRY","100579140","early-phase-1-safety-and-preliminary-efficacy-of-anti-cdh17-car-t-cell-therapy-in-patients-with-cdh17-positive-advanced-solid-tumors-100579140",false,"NCT06820424","Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Therapy in Patients with CDH17-positive Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of CDH17 CAR-T in Patients with CDH17-positive Advanced Solid Tumors","Inclusion Criteria:\n\n1. The patient understands and voluntarily signs the informed consent form, and is expected to complete the follow-up examination and treatment of the study procedures;\n2. Age 18-75 years old, gender unlimited;\n3. Tumor patients who have positive expression of CDH17 target in tumor tissues measured by immunohistochemistry (IHC) in a laboratory approved by the partner, and have no standard therapy or are ineffective or not suitable for standard treatment;\n4. Have at least one extracranial measurable lesion according to RECIST 1.1 criteria;\n5. Estimated survival ≥ 12 weeks;\n6. Baseline ECOG (Eastern Cooperative Oncology Group) score ≤ 1 point;\n7. The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade \\\u003C 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);\n8. Venous access could be established; without contraindications of apheresis.\n\nExclusion Criteria:\n\n1. Patients with prior or current other malignancies;\n2. Presence of brain metastases and clinically significant central nervous system disease;\n3. Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;\n4. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is higher than the lower limit of detection of the research institution; EBV DNA titer is higher than the lower limit of detection of the research institution\n5. Those who have a positive sputum smear and T-cell test for tuberculosis infection;\n6. Patients with objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function, both past and present;\n7. Patients have a severe allergic history;\n8. Patients with severe heart disease or uncontrollable refractory hypertension;\n9. Patients with severe liver and kidney dysfunction or consciousness disorders;\n10. Active autoimmune or inflammatory diseases of the nervous system;\n11. Uncontrolled infections that need antibiotics treatment;\n12. Live attenuated vaccine within 4 weeks before screening;\n13. Alcoholics or persons with a history of drug abuse;\n14. Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion;\n15. Any unsuitable to participate in this trial judged by the investigator.","ALL","18 Years","75 Years",{"count":66,"type":67},30,"ESTIMATED","INTERVENTIONAL",[70],"EARLY_PHASE1","This is a single-center, open-label, single-arm study to evaluate the safety and preliminary efficacy of anti-CDH17 CAR-T cells in patients with CDH17-positive advanced solid tumors.",[73],"CDH17-positive Advanced Solid Tumors",[75],"CDH17 CAR-T","2025-02-06",{"date":78,"type":79},"2025-02-11","ACTUAL",{"date":81,"type":67},"2025-03",{"date":83,"type":67},"2028-06",{"name":5,"class":6},1]