[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou Huasai Biomedicine Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100656740","phase-1-a-clinical-study-of-hs-it101-injection-in-patients-with-advanced-non-small-cell-lung-cancer-100656740",false,"NCT07830342","A Clinical Study of HS-IT101 Injection in Patients With Advanced Non-Small Cell Lung Cancer","A Phase Ib Clinical Study to Evaluate the Safety and Efficacy of HS-IT101 Injection in Patients With Advanced Non-Small Cell Lung Cancer.","Inclusion Criteria:\n\n1. Age 18 to 75 years;\n2. Patients with histologically or cytologically confirmed advanced, recurrent, or metastatic non-small cell lung cancer who have failed standard therapy or are intolerant to other standard therapies;\n3. At least one tumor lesion that has not received radiotherapy or other local treatment within 28 days and can be surgically resected and\u002For biopsied for the preparation of autologous tumor-infiltrating lymphocytes;\n4. After sampling, at least one measurable lesion as defined by RECIST 1.1 that has not received radiotherapy or other local treatment;\n5. ECOG performance status ≤ 1;\n6. Adequate organ and bone marrow function as assessed during the screening period;\n7. Left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography; no arrhythmia requiring treatment; Fridericia-corrected QT interval (QTcF) ≤ 470 ms; baseline oxygen saturation \\> 91% on room air;\n8. Prior treatment-related adverse events have recovered to ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) 6.0 before tumor sampling;\n9. Agree to use effective non-pharmacological contraceptive measures from the time of signing informed consent until 1 year after TIL cell infusion;\n10. Fully understand the trial and voluntarily sign the informed consent form, and be able to comply with the visits and related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Patients with a history of severe hypersensitivity reactions to any drug used during the study;\n2. Any uncontrolled clinical problem, including but not limited to: poorly controlled hypertension; congestive heart failure;\n3. Any of the following events within 6 months prior to screening: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, or coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism;\n4. Active autoimmune disease requiring systemic treatment during the study;\n5. History of organ transplantation or hematopoietic stem cell transplantation;\n6. Use of any immunosuppressive medications, such as corticosteroids, within 4 weeks prior to tumor tissue collection, or presence of a concurrent disease that, in the investigator's judgment, requires immunosuppressive medication during the study. However, physiological doses of glucocorticoids, intranasal or topical corticosteroids are allowed;\n7. Received systemic anticancer therapy within 4 weeks prior to preconditioning, or plan to participate in another interventional clinical trial during the study;\n8. Presence of acute or chronic infection, including: HIV positive, positive Treponema pallidum antibody, or clinically active hepatitis B or C; Active infection requiring systemic treatment or active tuberculosis infection;\n9. Major organ surgery or significant trauma within 4 weeks prior to screening, or requirement for elective surgery during the study;\n10. Surgical complications or delayed wound healing prior to screening that, in the investigator's judgment, would increase the risk of lymphodepleting preconditioning, adoptive TIL therapy, and IL-2 adjuvant therapy;\n11. Diagnosis of another primary malignancy within 5 years prior to screening, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For curatively resected carcinoma in situ;\n12. Severe respiratory disease;\n13. Gastrointestinal bleeding requiring surgical treatment, intestinal ischemia, or perforation;\n14. Known leptomeningeal metastasis; known other central nervous system metastases that are not effectively controlled after treatment or untreated;\n15. Previous treatment with a similar cell therapy product;\n16. Pregnant or breastfeeding women;\n17. Known psychiatric disorders, alcoholism, drug abuse, or substance abuse, and any other condition that the investigator considers unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","A Single-Arm, Open-Label, Interventional Study to Evaluate the Efficacy of HS-IT101 Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy After Lymphodepleting Preconditioning with Fludarabine and Cyclophosphamide and Subsequent Interleukin-2 Therapy in Patients with Advanced Non-Small Cell Lung Cancer.",[27],"Advanced NSCLC","RECRUITING","2026-09-24",{"date":31,"type":32},"2026-09-29","ACTUAL",{"date":34,"type":32},"2026-09-21",{"date":36,"type":21},"2028-10",{"name":38,"class":39},"Hangzhou Huasai Biomedicine Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":54,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":5},"100652164","phase-1-clinical-study-of-hs-it101-injection-in-the-treatment-of-advanced-renal-cancer-100652164","NCT07770802","Clinical Study of HS-IT101 Injection in the Treatment of Advanced Renal Cancer","A Phase Ib, Open-Label Clinical Study of HS-IT101 Injection in Patients With Advanced Renal Cancer","Inclusion Criteria:\n\n1. Aged 18 to 75 years old, regardless of gender;\n2. Pathologically confirmed by histology and\u002For cytology as metastatic or unresectable clear cell renal cell carcinoma (defined as clear cell component accounting for more than 50%), and has experienced treatment failure after at least one previous first-line standard therapy;\n3. Before screening, there is at least one biopsiable lesion that has not received radiation therapy or other local treatments (such as ablation therapy, oncolytic virus, etc.) within 28 days, and the lesion meets the sampling requirements;\n4. After tumor tissue sampling, there is at least one measurable tumor lesion defined by the RECIST 1.1 criteria (Lesions located in areas that have received previous local treatment, including previous radiotherapy, are not considered measurable lesions, unless it is confirmed that the lesion in this area has developed disease progression as defined by RECIST 1.1 after local treatment); (5) ECOG performance status is 0 or 1;\n\n(6) Expected survival time ≥ 3 months; (7) Evaluated via laboratory and other examinations during the screening period, the participant has good organ function; (8) Before tumor tissue collection, adverse reactions caused by previous treatment have recovered to ≤ Grade 1 in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) 6.0, except for toxicities that investigators judge have no safety risk, such as hyperthyroidism and hair loss; (9) Agree to take effective non-drug contraceptive measures from the date of signing the informed consent form to the end of the study; (10) Fully understand this trial, voluntarily sign the informed consent form, and are able to comply with the visit and relevant procedures specified in the study protocol.\n\nExclusion Criteria:\n\n1. Use of any immunosuppressive medications, such as corticosteroids, within 4 weeks prior to tumor tissue collection, or presence of a concurrent disease requiring immunosuppressive medication during the study as judged by the investigator. Intranasal or topical corticosteroid use is allowed.\n2. Major organ surgery or significant trauma within 4 weeks prior to screening, or requirement for elective surgery during the study, except cytoreductive surgery performed for tumor tissue collection.\n3. Received systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to tumor tissue collection.\n4. Received a live vaccine within 3 months prior to screening, or plans to receive a live vaccine during the study.\n5. History of severe hypersensitivity reaction to any drug used in the study.\n6. Prior treatment with similar cell therapy products.\n7. Prior organ transplantation or hematopoietic stem cell transplantation.\n8. Gastrointestinal bleeding requiring surgical treatment, intestinal ischemia, or perforation.\n9. Any of the following events within 6 months prior to screening: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism.\n10. Diagnosis of another primary malignancy within 5 years prior to screening, except curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For curatively resected carcinoma in situ.\n11. Pleural effusion, pericardial effusion, or ascites that remains uncontrolled despite drainage or requires repeated drainage.\n12. Surgical complications or delayed wound healing prior to screening that, in the investigator's judgment, would increase the risk of study treatment.\n\n13Severe respiratory disease. 14.Known leptomeningeal metastasis; symptomatic central nervous system (CNS) metastases. Participants with previously treated brain metastases who are clinically stable (as confirmed by MRI) for at least 12 weeks may be enrolled.\n\n15.Any uncontrolled clinical condition. 16.Active autoimmune disease requiring systemic treatment during the study. 17.Presence of acute or chronic infection. 18.Pregnant or breastfeeding women. 19.Known psychiatric illness, alcoholism, drug abuse, or substance abuse. 20.Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.",{"count":49,"type":21},15,[24],"A Single-Arm, Open-Label, Interventional Study to Evaluate the Efficacy of HS-IT101 Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy After Lymphodepleting Preconditioning with Fludarabine and Cyclophosphamide and Subsequent Interleukin-2 Therapy in Patients with Advanced Renal Cancer.",[53],"Clear Cell Renal Cell Carcinoma",{"date":31,"type":32},{"date":56,"type":32},"2026-08-23",{"date":58,"type":21},"2028-08",{"name":38,"class":39},""]