[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589208":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":41,"collaborators":45,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":20,"overallStatus":68,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Shanghai Tongji Hospital, Tongji University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment of B7H3+ solid tumors","EXPERIMENTAL","Intraperitoneal Infusion for Ovarian Cancer and Peritoneal Metastatic Tumors; Intravenous Infusion for Other Types of Solid Tumors",[13],"Drug: TH-CART-027",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","TH-CART-027","3+3 dose escalation design: Dose Level 1: 0.3×10\\^6 CAR+ T cells \u002Fkg; Dose Level 2: 1.0×10\\^6 CAR+ T cells \u002Fkg; Dose Level 3: 3.0×10\\^6 CAR+ T cells \u002Fkg",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Liying Chen","CONTACT","+86 15618670468","lab7182@tongji.edu.cn",[28],{"facility":5,"status":20,"city":29,"state":20,"zip":20,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Shanghai","China","CN",{"type":33,"coordinates":34},"Point",[35,36],121.45806,31.22222,{"lat":36,"lon":35},[39],{"name":23,"role":24,"phone":40,"phoneExt":20,"email":26},"+8615618670468",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Aibin Liang","Professor, Chief Physician, Vice President of Tongji Hospital, Tongji University School of Medicine etc.",[46],{"name":47,"class":48},"ThinkingBiomed","UNKNOWN","100589208","early-phase-1-an-exploratory-clinical-study-of-the-efficiency-and-safety-of-th027-in-the-treatment-of-relapsedrefractory-solid-tumors-100589208",false,"NCT06951425","An Exploratory Clinical Study of the Efficiency and Safety of TH027 in the Treatment of Relapsed\u002FRefractory Solid Tumors","A Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerability and Antitumor Activity of TH027 CAR-T Cells (TH-CART-027) in Subjects With Relapsed or Refractory Solid Tumors","Inclusion Criteria:\n\n* 1.The patients were aged from 18 to 75 years old (including the cut-off value), and the gender was not limited;\n* 2.The expected survival time was more than 12 weeks;\n* 3.ECOG score was 0-2;\n* 4.One of the following tumor types was confirmed by pathology: osteosarcoma, neuroblastoma, gastric cancer or lung cancer, and the positive rate of CD276 expression in tumor tissue was more than 30% by immunohistochemistry;\n* 5.Patients with ineffective standard treatment methods (such as postoperative recurrence, chemotherapy, radiotherapy, and progression after targeted drugs);\n* 6.According to RECIST 1.1, there was at least one measurable lesion (the longest diameter of solid lesion \\>=10 mm, or the short diameter of lymph node lesion \\>=15 mm);\n* 7.The function of main organs was normal (white blood cell count \\>= 3 × 10\\^9 \u002F L, neutrophil count \\>= 1.5 × 10\\^9 \u002F L, hemoglobin \\>= 8.5g\u002Fdl, platelet count \\>= 80 × 10\\^9 \u002F L and lymphocyte count at 1 × 10\\^9 \u002F L (including) \\~ 4 × 10\\^9 \u002F L (inclusive);\n* 8.The liver and kidney function and cardiopulmonary function meet the following requirements:\n* Urea and serum creatinine \\\u003C= 1.5 × ULN；\n* Left ventricular ejection fraction \\>= 50%;\n* Baseline oxygen saturation \\>= 94%;\n* Total bilirubin \\\u003C= 1.5 × ULN； ALT and AST \\\u003C= 2.5 × ULN；\n* 9.The patient or legal representative can fully understand the significance and risk of this trial and has signed the informed consent.\n\nExclusion Criteria:\n\n* 1.Patients with history of immune deficiency or autoimmune diseases (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); Patients with graft-versus-host disease (GVHD) or need immunosuppressive agents;\n* 2.There was a history of other second malignancies in 5 years before screening;\n* 3.Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) were positive, and the peripheral blood HBV DNA titer was not within the normal reference value; HCV antibody and HCV RNA in peripheral blood were positive; HIV antibody positive patients; Syphilis was positive;\n* 4.Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification \\>= III), severe arrhythmia;\n* 5.Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;\n* 6.Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection);\n* 7.Pregnant or lactating women, female subjects who plan to conceive within one year after cell transfusion, or male subjects whose partners plan to conceive within one year after cell transfusion;\n* 8.Patients who had received CAR-T therapy or other gene modified cell therapy before screening;\n* 9.The subjects who were receiving systemic steroid treatment within 7 days before the screening or who needed long-term systemic steroid treatment (except inhalation or local use) were determined by the researchers;\n* 10.The ascites increased gradually after 2 weeks of conservative treatment (such as diuresis, sodium restriction, excluding ascites drainage);\n* 11.According to the judgment of the researcher, it does not conform to the situation of cell preparation;\n* 12.Other researchers think that it is not suitable for inclusion.","ALL","18 Years","75 Years",{"count":60,"type":61},24,"ESTIMATED","INTERVENTIONAL",[64],"EARLY_PHASE1","This is a Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerabilityand Antitumor Activity of TH027 CAR-T Cell lnjection (TH-CART-027) in Subjects With Relapsed or Refractory Solid Tumors.",[67],"Solid Tumors","NOT_YET_RECRUITING","2025-05-12",{"date":71,"type":72},"2025-05-13","ACTUAL",{"date":74,"type":61},"2025-06-01",{"date":76,"type":61},"2028-11-30",{"name":5,"class":6},1]