[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-of-penis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-of-penis":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100512476","phase-1-hryz-t101-injection-for-hpv18-positive-solid-tumor-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":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32],"Cervical Cancer","Head and Neck Squamous Cell Carcinoma","Carcinoma of Vagina","Carcinoma of Penis","Anal Cancer","Carcinoma of Vulva","RECRUITING","2024-01-31",{"date":36,"type":37},"2024-02-02","ACTUAL",{"date":39,"type":37},"2023-11-01",{"date":41,"type":21},"2028-02",{"name":43,"class":44},"HRYZ Biotech Co.","INDUSTRY"]