[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"HRYZ Biotech Co.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"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":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100537386","phase-2-masct-i-combined-with-doxorubicin-and-ifosfamide-for-first-line-treatment-of-advanced-soft-tissue-sarcoma-100537386",false,"NCT06277154","MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma","A Phase II Study Evaluating the Safety and Efficacy of MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment in Patients With Advanced Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Age≥18 years and≤70 years;\n2. According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas, including leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumors, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, desmoplastic small round cell tumor.\n3. No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of the end of neoadjuvant or adjuvant therapy.\n4. At least one measurable and assessable lesion defined by RECIST 1.1;\n5. ECOG performance status of 0-1;\n6. Estimated life expectancy≥6 months;\n7. Pulmonary function is basically normal;\n8. Subjects with organ function as defined below (any blood components and growth factors are not allowed within 14 days before apheresis): a) Hemoglobin ≥90g\u002FL; b) Leukocyte≥3.5x10\\^9\u002FL; c) The absolute neutrophil count (ANC)\\>1.5x10\\^9\u002FL; d) Platelet≥100x10\\^9\u002FL; e) ALT, AST≤2.5 ULN (Upper Limit of Normal), ALT, AST≤5 ULN for liver metastases; f) ALP≤2.5 ULN; g) Serum total bilirubin≤1.5 ULN; Patients with Gilbert's syndromes (persistent or repeated hyperbilirubinemia \\[mainly unconjugated bilirubin\\], in the absence of evidence of hemolysis or liver disease), are allowed to enroll with investigator's agreement; h) Serum urea nitrogen or urea and creatinine≤2.5 ULN; i) Serum albumin≥35g\u002FL; j) PT, APTT, INR≤1.5 ULN (without anticoagulation treatment);\n9. Obtain the written informed consent of the patient\u002Flegal representative;\n10. Subjects with potential fertility must agree to use effective contraceptive measure during and within 6 months after the treatment period. HCG test for female with potential fertility must be negative before the study was included.\n\nExclusion Criteria:\n\n1. Previous treatment with targeted therapy, radiotherapy (radiotherapy to non-target lesions or disease progressed after radiotherapy could be included.) or other antineoplastic drugs such as anlotinib, gemcitabine, within 4 weeks before randomization, or have received Chinese medicine or proprietary Chinese medicine for anti-tumor treatment within 2 weeks before randomization.\n2. Highly differentiated liposarcoma, malignant perivascular epithelioid tumor, protuberant cutaneous fibrosarcoma, extraosseous osteosarcoma, solitary fibroma\u002Fhemangiopericytoma, acinous soft tissue sarcoma, extraosseous myxoid chondrosarcoma, gastrointestinal stromal tumor, invasive fibroma, renal angiomyolipoma, malignant mesothelioma, clear cell sarcoma, Ewing's sarcoma, etc., which are not suitable for Doxorubicin+ Ifosfamide (AI) treatment.\n3. Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg\u002Fm2 doxorubicin.\n4. Previous treatment with MASCT, or have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year.\n5. Use of immunosuppressive agents or systemic or inhaled local hormones (exceeding 10mg\u002Fday prednisone or its equivalent) and were still using them within 2 weeks before randomization.\n6. Use of immunomodulators and were still using them within 2 weeks before randomization.\n7. Allergic to sodium citrate or human albumin.\n8. Subjects with uncontrolled pleural effusion and abdominal effusion requiring repeated drainage and with moderate or higher volume of pericardial effusion.\n9. Have known active central nervous system (CNS) or meningeal metastases. Subjects with previously treated brain metastases may participate provided they are stable based on the following: 1) any neurologic symptoms have returned to baseline at least 2 weeks before randomization, 2) no requirement for steroids at least 2 weeks before randomization or receiving low-dose of steroids (Not exceeding 10mg\u002Fday prednisone or its equivalent).\n10. Have any active autoimmune disease or history of autoimmune disease.\n11. Subjects with active tuberculosis.\n12. Subjects were infected with hepatitis B virus, hepatitis C virus or HIV, or syphilis.\n13. Severe cardiovascular disease, such as: (1) complete left bundle branch block or III atrioventricular block; (2) history of myocardial infarction, angioplasty, coronary artery bypass graft; (3) prolonged QT\u002FQTc interval at baseline (male\\>450ms, female \\>480ms); (4) LVEF≤50%; (5) heart failure of NYHA class 2 or higher; (6) poorly controlled hypertension (BP≥150\u002F95 mmHg, despite optimal medical treatment); (7) cardiomyopathy or severe arrhythmia and may have impact on the study based on investigator's judgement.\n14. Subjects with history of thrombus or experienced a cerebrovascular accident within 6 months before randomization;\n15. Other malignant tumors (except cured skin basal cell carcinoma, prostate carcinoma in situ and cervical carcinoma in situ) in the past 5 years;\n16. Known history of organ transplantation or ready to receive an organ transplantation;\n17. Subjects who have undergone major surgery or traumatic injury within 4 weeks before randomization;\n18. Those who have a history of alcohol dependence, psychotropic substance abuse and cannot abstain or have mental disorders.\n19. Surgery for soft tissue sarcoma is planned during the study.\n20. Subjects have participated in another investigational trial within 4 weeks before randomization.\n21. Any condition that the investigator considers to be prejudicial to the subject or to the subject's inability to meet or perform the study requirements exists.","ALL","18 Years","70 Years",{"count":20,"type":21},148,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.",[27,28,29,30,31,32,33,34,35,36,37],"Leiomyosarcoma","Liposarcoma","Synovial Sarcoma","Angiosarcoma","Undifferentiated Pleomorphic Sarcoma","Epithelioid Sarcoma","Malignant Peripheral Nerve Sheath Tumors","Fibrosarcoma","Pleomorphic Rhabdomyosarcoma","Endometrial Stromal Sarcoma","Desmoplastic Small Round Cell Tumor","RECRUITING","2025-07-20",{"date":41,"type":42},"2025-07-24","ACTUAL",{"date":44,"type":42},"2024-02-21",{"date":46,"type":21},"2027-02",{"name":48,"class":49},"HRYZ Biotech Co.","INDUSTRY",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":50},"100512476","phase-1-hryz-t101-injection-for-hpv18-positive-solid-tumor-100512476","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.","75 Years",{"count":60,"type":21},32,[62],"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.",[65,66,67,68,69,70],"Cervical Cancer","Head and Neck Squamous Cell Carcinoma","Carcinoma of Vagina","Carcinoma of Penis","Anal Cancer","Carcinoma of Vulva","2024-01-31",{"date":73,"type":42},"2024-02-02",{"date":75,"type":42},"2023-11-01",{"date":77,"type":21},"2028-02",{"name":48,"class":49},""]