[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512476":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":55,"studyPopulation":55,"armGroups":59,"interventions":67,"overallOfficials":77,"centralContacts":84,"locations":90,"responsibleParty":108,"collaborators":55,"id":110,"slug":55,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":55,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":55,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":55,"overallStatus":93,"whyStopped":55,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"HRYZ Biotech Co.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":42},[9,13],{"measure":10,"description":11,"timeFrame":12},"DLT","Dose-limiting toxicity","28 days",{"measure":14,"description":15,"timeFrame":16},"Adverse events and serious adverse events","Incidence of adverse events and serious adverse events","2 years",[18,21,24,27,30,33,36,39],{"measure":19,"description":20,"timeFrame":16},"Objective Response Rate（ORR）","The percentage of subjects with PR or CR assessed by RECIST 1.1.",{"measure":22,"description":23,"timeFrame":16},"Disease Control Rate (DCR)","The percentage of subjects with a confirmed CR, PR, or stable disease (SD) assessed by RECIST 1.1.",{"measure":25,"description":26,"timeFrame":16},"Duration of response (DoR)","Subjects who show a confirmed CR or PR as assessed by RECIST 1.1.",{"measure":28,"description":29,"timeFrame":16},"Time to response (TTR)","Time from date of T-cell administration to first documented evidence of confirmed (CR or PR) as assessed by RECIST 1.1.",{"measure":31,"description":32,"timeFrame":16},"Progression-Free Survival（PFS）","The length of time from enrollment until the time of progression of disease.",{"measure":34,"description":35,"timeFrame":16},"Overall Survival (OS)","The interval of time between the date of T-cell infusion and the date of death.",{"measure":37,"description":38,"timeFrame":16},"Duration of TCR T cells in-vivo persistence","Blood samples were collected to measure persistence of infused HRYZ-T101.",{"measure":40,"description":41,"timeFrame":16},"Concentration of Cytokines (IL-2、IL-6、IL-10、TNFα、IFNγ)","Collect blood samples and analyze for presence of cytokines (IL-2、IL-6、IL-10、TNFα、IFNγ) at specified intervals before and after treatment with HRYZ-T101.",[43,46,49],{"measure":44,"description":45,"timeFrame":16},"Number of Subjects with positive anti-drug antibodies (ADA)","Serum samples will be collected to analyze for the presence of ADAs using validated immunoassays.",{"measure":47,"description":48,"timeFrame":16},"Number of subjects with replication competent lentivirus (RCL)","RCL exposure will be assessed by polymerase chain reaction (PCR) based assay.",{"measure":50,"description":51,"timeFrame":16},"T cell subgroup in peripheral blood","Collect blood samples and analyze for T cell subgroup by flow cytometry at specified intervals before and after treatment with HRYZ-T101.",{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":55,"timePerspective":55,"maskingInfo":57},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":58,"maskingDescription":55,"whoMasked":55},"NONE",[60],{"label":61,"type":62,"description":63,"interventionNames":64},"HRYZ-T101 Injection","EXPERIMENTAL","Patients will undergo lymphocytapheresis, then treatment with HRYZ-T101 TCR-T cells.",[65,66],"Biological: HRYZ-T101 Injection","Drug: Fludarabine + Cyclophosphamide",[68,72],{"type":69,"name":61,"description":70,"armGroupLabels":71,"otherNames":55},"BIOLOGICAL","On day 1, the TCR-T cells will be administered intravenously.",[61],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":55},"DRUG","Fludarabine + Cyclophosphamide","Fludarabine: 25mg\u002Fm²\u002Fday×3days; Cyclophosphamide: 250mg\u002Fm²\u002Fday×3 days",[61],[78,82],{"name":79,"affiliation":80,"role":81},"Xiaohua Wu, Doctor","Fudan University","PRINCIPAL_INVESTIGATOR",{"name":83,"affiliation":80,"role":81},"Jian Zhang, Doctor",[85],{"name":86,"role":87,"phone":88,"phoneExt":55,"email":89},"Xuemin Rao","CONTACT","021-61049928","raoxuemin@shhryz.com",[91],{"facility":92,"status":93,"city":94,"state":95,"zip":55,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":99,"coordinates":100},"Point",[101,102],121.45806,31.22222,{"lat":102,"lon":101},[105,106,107],{"name":86,"role":87,"phone":55,"phoneExt":55,"email":89},{"name":83,"role":81,"phone":55,"phoneExt":55,"email":55},{"name":79,"role":81,"phone":55,"phoneExt":55,"email":55},{"type":109,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100512476",false,"NCT05952947","HRYZ-T101 Injection for HPV18 Positive Solid Tumor","A Multicenter, Single Arm, Open Label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of HRYZ-T101 Injection for HPV18 Positive Solid Tumor","Inclusion Criteria:\n\n* 1\\. The patient must be willing to sign the informed consent form.\n* 2\\. Age ≥18 years and ≤75 years.\n* 3\\. Metastatic or recurrent solid tumors with confirmed HPV18 infection based on TNM \\& FIGO staged histopathological investigation. .\n* 4\\. Subjects who have failed anti-tumor treatment in the past and lack effective treatment options.\n* 5\\. HPV18 positive and HLA-DRB1\\*0901 allele.\n* 6\\. ECOG performance status ≤1.\n* 7\\. Estimated life expectancy ≥ 3 months.\n* 8\\. Patients must have at least one measurable lesion defined by RECIST 1.1.\n* 9\\. Patients with any organ dysfunction as defined below:\n\n  1. Leukocytes≥3.0 x 10\\^9\u002FL;\n  2. blood platelets ≥75 x 10\\^9\u002FL;\n  3. hemoglobin≥85g\u002FL;\n  4. Absolute lymphocyte count≥0.8 x 10\\^9\u002FL\n  5. Serum albumin ≥ 30g\u002FL;\n  6. total bilirubin≤1.5×ULN; ALT\u002FAST≤3×ULN or ≤5×ULN for liver metastases;\n  7. Creatinine clearance ≥50mL\u002Fmin; or serum creatinine ≤1.5×ULN;\n  8. INR≤1.5×ULN; APTT≤1.5×ULN;\n  9. LVEF≥50%;\n  10. SpO2≥92%.\n* 10\\. Subjects with potential fertility must agree to use effective contraceptive methods during the whole trials period and at least 1 year after receiving HRYZ-T101 cell transfusion treatment. HCG test for female with potential fertility must be negative within 7 days before apheresis.\n\nExclusion Criteria:\n\n* 1\\. Have a history of hypersensitivity to cyclophosphamide or fludarabine, and it is known that any ingredient used in the treatment of this study will produce allergic reactions.\n* 2\\. Those who have undergone systemic anti-tumor treatment within 4 weeks before apheresis, including who have received conventional chemotherapy, large-area radiotherapy, targeted therapy, immunotherapy or biological therapy, and other anti-tumor treatment. Have received small molecule targeted drugs and oral fluorouracils or Chinese herbal medicine within 2 weeks before apheresis.\n* 3\\. Have received any investigational drug within 4 weeks before apheresis, or have participated in another clinical study at the same time.\n* 4\\. Have received any cell therapy products before.\n* 5\\. Those who have undergone major surgery within 4 weeks before apheresis, or minor surgery within 2 weeks before apheresis.\n* 6\\. Toxicity of previous treatment has not been mitigated or ≤ Grade 1 before apheresis.\n* 7\\. Have received live attenuated vaccine or adenovirus vector vaccine within 4 weeks before apheresis.\n* 8\\. Have central nervous system metastasis with symptoms.\n* 9\\. Subjects with clinical cardiac symptoms or diseases that cannot be well controlled.\n* 10\\. Subjects with serious or uncontrolled systemic disease or any unstable systemic disease.\n* 11\\. Subjects with active infection requiring systemic treatment with anti-infective drugs within 2 weeks before apheresis.\n* 12\\. Subjects have any active autoimmune disease or history of autoimmune disease.\n* 13\\. Have received immunosuppressive agents, or systemic corticosteroids, immunomodulators within 2 weeks before apheresis.\n* 14\\. Subjects with other malignant tumors. Except for: (1) Carcinoma in situ with curative treatment and no evidence of recurrence for at least 2 years; (2) the primary malignant tumor has been completely resected and achieved CR for ≥ 2 years.\n* 15\\. Subjects with history of thromboembolism ≥ Grade 3 within 6 months before apheresis, or is receiving thrombolytic or anticoagulant for high-risk of thromboembolism.\n* 16\\. Known HIV or syphilis infection, and\u002For active hepatitis B virus or hepatitis C virus infection.\n* 17\\. Organ transplanters and allogeneic cell transplanters.\n* 18\\. Subjects with active pulmonary tuberculosis infection within 1 year or have not received treatment at least 1 year before apheresis.\n* 19\\. Pregnant or lactating female, or those whose HCG test is positive before enrollment.\n* 20\\. According to the judgment of the researcher, those who are not suitable for the group, such as poor compliance.","ALL","18 Years","75 Years",{"count":120,"type":121},32,"ESTIMATED","INTERVENTIONAL",[124],"PHASE1","A multicenter, open label, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of HRYZ-T101 injection for HPV18 positive solid tumor. The study will investigate RP2D of HRYZ-T101 TCR-T cell injection.",[127,128,129,130,131,132],"Cervical Cancer","Head and Neck Squamous Cell Carcinoma","Carcinoma of Vagina","Carcinoma of Penis","Anal Cancer","Carcinoma of Vulva","2024-01-31",{"date":135,"type":136},"2024-02-02","ACTUAL",{"date":138,"type":136},"2023-11-01",{"date":140,"type":121},"2028-02",{"name":5,"class":6},1]