[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559324":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":35,"studyPopulation":28,"armGroups":36,"interventions":43,"overallOfficials":28,"centralContacts":28,"locations":51,"responsibleParty":86,"collaborators":28,"id":90,"slug":28,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":28,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":28,"studyType":102,"phases":103,"briefSummary":104,"conditions":105,"keywords":28,"overallStatus":54,"whyStopped":28,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":100},{"fullName":5,"class":6},"Cell Origin Biotech (Hangzhou) Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Identification of Maximum Tolerated Dose (MTD)","MTD will be determined based on DLTs observed during the first 28 days of study treatment.","up to 28 days after SY001 infusion.",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Objective response rate (ORR)","Treatment response was assessed according to the criteria of RECIST 1.1, with PET-CT scans being the primary method used to evaluate tumor progression.","3 months",{"measure":19,"description":20,"timeFrame":21},"Time to Peak (Tmax)","Changes in the CAR gene copy number after infusion of SY001; time to peak (Tmax) from 0 to 1 month.","1 month",{"measure":23,"description":24,"timeFrame":21},"Area Under the Plasma Concentration Versus Time Curve (AUC)","Changes in the CAR gene copy number after infusion of SY001, area under the concentration-time curve (AUC) from 0 to 1 month",{"measure":26,"description":27,"timeFrame":21},"Maximum Plasma Concentration of cytokines (Cmax)","Changes in cytokines in peripheral blood after infusion of SY001.",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"NA","SINGLE_GROUP","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":28},"NONE","This study was a single-arm, single-center, dose-increasing design, using the \"3+3\" approach for dose escalation, to evaluate the safety, tolerability and initial effectiveness of SY001, and to evaluate the pharmacokinetic characteristics, cytokines and the correlation between the efficacy of SY001.",[37],{"label":38,"type":39,"description":40,"interventionNames":41},"SY001 Targets Mesothelin positive solid tumors in a Dose-increasing Setting","EXPERIMENTAL","Patients with mesothelin-positive ovarian cancer were treated with an SY001 injection in combination with an anti-PD-1 antibody. Patient 001 received 1109 SY001 CAR-pMACs via intravenous injection. Following a two-month period in which the treatment's safety was confirmed, this patient underwent another two does of 1109 SY001 cells on both day 1 and day 3. Prior to the CAR-pMACs infusion on day 1, a PD1 antibody Tislelizumab Injection was administered. In the case of the patient 002, SY001 treatment was delivered intravenously on three occasions: day 1, day 3, and day 5. The same as the first patient's protocol, Tislelizumab was given prior to the CAR-pMACs on day 1.",[42],"Drug: SY001",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","SY001","PBMC-derived anti-mesothelin Cheimeric Antigen Receptor macrophages",[38],[50],"CAR-pMAC",[52,72],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"The First Affiliated Hospital, Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":61,"coordinates":62},"Point",[63,64],120.16142,30.29365,{"lat":64,"lon":63},[67],{"name":68,"role":69,"phone":70,"phoneExt":28,"email":71},"Jianhua Qian, PHD","CONTACT","17816142153","qianjianhua@zju.edu.cn",{"facility":73,"status":74,"city":75,"state":28,"zip":28,"country":58,"countryCode":59,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Linyi Cancer Hospital","NOT_YET_RECRUITING","Linyi",{"type":61,"coordinates":77},[78,79],118.34278,35.06306,{"lat":79,"lon":78},[82],{"name":83,"role":69,"phone":84,"phoneExt":28,"email":85},"Xiumin Li","+86 18868115772","Lyzlyylxm@163.com",{"type":87,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Xudong Wang","manager","100559324",false,"NCT06562647","SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors","An Exploratory Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SY001 Injection Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients with pathologically diagnosed advanced ovarian cancer\u002Fpancreatic cancer who have failed at least 1 prior lines treatment, and tumor tissue samples were positive for mesothlin IHC staining;\n2. According to the RECIST 1.1, there is measurable tumor lesions (non-lymph node lesion 10mm in length or lymph node lesion 15mm in diameter measured by CT or MRI, with scan layer thickness 5mm);\n3. Eastern Cooperative Oncology Group (ECOG) score of 2 and satisfactory major organ functions;\n4. Estimated life expectancy \\>3 months;\n5. Female patients of childbearing age must undergo a serum pregnancy test at screening and prior to pretreatment and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection;\n3. Patients who have a history of other mesothelin-targeting therapy;\n4. Patients who have a history of autoimmune disease;\n5. The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol.","FEMALE","18 Years","75 Years",{"count":100,"type":101},2,"ESTIMATED","INTERVENTIONAL",[30],"Single-arm, dose-increasing setting study of CAR macrophages in Mesothelin overexpressing solid tumors.",[106,107],"Treatment Related Cancer","Ovarian Cancer","2026-02-12",{"date":110,"type":111},"2026-02-13","ACTUAL",{"date":113,"type":111},"2023-04-12",{"date":115,"type":101},"2027-12",{"name":5,"class":6}]