[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tumor-associated-lymph-node-t-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tumor-associated-lymph-node-t-cell":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100571159","phase-1-a-phase-i-trial-of-tumor-associated-lymph-node-t-cell-injection-with-advanced-malignant-solid-tumors-100571159",false,"NCT06716619","A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid Tumors","A Phase I Clinical Trial of the Safety and Tolerability of Tumor-Associated Lymph Node T-Cell Injection (TAL-T) in Subjects With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Sign a written informed consent (ICF) and be able to comply with the visit and related procedures required by the program;\n2. Age ≥18 years old, and ≤75 years old, male and female;\n3. ECOG score 0-1;\n4. Expected survival is not less than 12 weeks;\n5. Advanced malignant solid tumors confirmed by cytology or histopathology (tumor markers combined with imaging can be used for some special advanced tumors, such as liver cancer) that have failed standard treatment or lack effective treatment methods, including but not limited to melanoma, head and neck tumors, cervical cancer, non-small cell lung cancer, etc.\n\n   \"Standard treatment failure\" refers to the occurrence of disease progression after enough treatment courses and sufficient lines of treatment with the existing standard recommended therapy (refer to the latest CSCO guidelines), or recurrence after the regression of the tumor after standard treatment, or the toxic side effects of standard treatment are not tolerated.\n6. There are tumor-associated lymph nodes that can be resected and T cells can be isolated: the tissue taken is ≥1 cm3, and the site has not received local treatment or has progressed after local treatment;\n7. After sampling, subjects still have at least one evaluable lesion (Extended enrollment phase according to RECIST v1.1, subjects still have at least one measurable lesion (lesions that have received local treatment such as radiotherapy, interventional therapy, etc., cannot be considered as measurable lesions unless imaging evidence confirms clear progression of the lesion). That is, CT or MRI examination of non-lymph node lesions with the longest diameter ≥10 mm, and\u002For lymph node lesions with a short diameter ≥15 mm);\n8. The subject has sufficient organ and bone marrow function (no blood transfusion or hematopoietic stimulating factors can be received within 14 days prior to screening)\n9. Fertile men and women of reproductive age must agree to use effective contraception from the time they sign the ICF until one year after cell transfusion, and women of reproductive age must have a negative blood pregnancy test at the time of screening.\n\nExclusion Criteria:\n\n1. meningeal metastases, and\u002For active brain metastases;\n2. Have previously received allogeneic bone marrow transplantation, organ transplantation or are waiting for transplantation;\n3. HBsAg positive hepatitis B; HCV-Ab positive hepatitis C; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis antibody positive; Cytomegalovirus (CMV) IgM antibody positive; Human herpesvirus type 4 (EBV) IgM positive; Human T-lymphocytophilic virus (HTLV-Ⅰ\u002FⅡ) antibody positive;\n4. Received any fluorouracil chemotherapeutic drugs or small molecule targeted drugs within 14 days or 5 half-lives (whichever is shorter) prior to pretreatment; Received any antitumor biologic or non-fluorouracil chemotherapeutic drugs within 28 days or 5 half-lives (whichever is shorter) prior to pretreatment; Received radical radiotherapy or extensive radiotherapy within 28 days prior to pretreatment (except local non-target palliative radiotherapy for symptom relief within 14 days prior to pretreatment); Received Chinese medicine\u002FChinese herbal medicine with anti-tumor indications and local interventional therapy within 14 days prior to pretreatment;\n5. Adverse events resulting from previous antitumor therapy have not returned to grade 1 or baseline levels (except for alopecia, grade 2 peripheral neurotoxicity, hypothyroidism controlled by alternative therapy and other toxicities that the investigators judged to be of no safety risk);\n6. Persons who had been immunized with live attenuated vaccine within 28 days prior to pretreatment, or who required live attenuated vaccine immunization during the study period;\n7. Had major surgery within 28 days prior to pretreatment, or required major surgery during the study period;\n8. Long-term (≥3 days) treatment with systemic corticosteroids (dose ≥10 mg\u002F day of prednisone or equivalent hormone) or other immunosuppressive agents, except for inhalation or local use, is required 7 days before the tumor-associated lymph node excision sampling or during the study period;\n9. Subjects with active systemic infections requiring intravenous antibiotic treatment within 7 days prior to screening;\n10. Patients with active or past autoimmune diseases that are likely to recurs, such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc. (subjects with hypothyroidism requiring only thyroid hormone replacement therapy, and subjects with type 1 diabetes requiring only insulin replacement therapy can be enrolled);\n11. Previous or current cases of interstitial lung disease, coniosis, radiation pneumonia, severe impairment of lung function, etc.;\n12. Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis, liver failure;\n13. Third space effusion with poor clinical control before screening, such as pleural fluid and ascites that cannot be controlled by drainage or other methods;\n14. Have a history of severe cardiovascular and cerebrovascular disease\n15. Patients with pulmonary embolism or severe deep venous thrombosis of lower extremities during screening, requiring interventional therapy such as inferior vena cava filter placement, or using therapeutic dose of anticoagulants;\n16. Any CTCAE 5.0 immune-related adverse reactions (irAE) grade ≥3 during any prior immunotherapy;\n17. Those with immune checkpoints (such as PD-1) for treatment of other contraindications;\n18. Subjects are participating in other interventional clinical studies;\n19. Pregnant or lactating women;\n20. The investigator believes that the subjects have other conditions that may affect their compliance or are not suitable to participate in the study.","ALL","18 Years","75 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","A Phase I clinical trial of the safety and tolerability of tumor-associated lymph node T cell injection in patients with advanced malignant solid tumors, including but not limited to melanoma, head and neck tumors, cervical cancer, and non-small cell lung cancer.",[27,28,29,30],"Tumor Associated Lymph Node T Cell","Advanced Solid Tumor","Immunotherapy","Serplulimab Injection",[29,28,27,32,33,30,34,35,36],"TAL-T","cell therapy","Adverse Drug Event","Efficacy","Safety","RECRUITING","2025-03-24",{"date":40,"type":41},"2025-03-26","ACTUAL",{"date":43,"type":41},"2025-02-13",{"date":45,"type":21},"2027-12-19",{"name":47,"class":48},"Guangzhou FineImmune Biotechnology Co., LTD.","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":32,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":49},"100539301","phase-1-phase-i-clinical-study-of-tumor-associated-lymph-node-t-cell-therapy-for-advanced-solid-tumors-100539301","NCT06302062","Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors","An Open,Single-center,Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors","Before conducting tumor-associated lymph node sampling, it is necessary to verify that subjects meet the inclusion criteria marked with an asterisk (\\*). These criteria include:\n\n1. \\* being between the ages of 18 and 75;\n2. having metastatic or locally advanced refractory\u002Frecurrent malignant solid tumors that have failed standard therapy or have failed to tolerate standard treatment;\n3. having at least one measurable target lesion;\n4. \\* voluntarily participating and signing an informed consent form;\n5. \\* having at least one resectable tumor-associated lymph node from which T cells can be successfully isolated;\n6. \\* having an ECOG score of 0-1;\n7. \\* having an expected survival of more than 6 months;\n8. \\* female subjects with fertility potential must have a negative pregnancy test, and all men and women with fertility potential must consent to using medically effective contraception during the study period and for 12 months after the last dose of the study medication;\n9. \\* being willing to regularly come to the hospital for treatment, testing, evaluation, and management as required during the entire study period.\n\nBefore sampling tumor-associated lymph nodes, it is important to confirm that the subject does not meet any of the exclusion criteria marked with an asterisk (\\*). These criteria include：\n\n1. \\* Experiencing moderate to severe infection or at risk of opportunistic infection;\n2. \\* Present with active autoimmune disease (other than vitiligo or childhood asthma\u002Fallergies that have healed);\n3. \\* Uncontrolled concomitant disease, including but not limited to symptomatic congestive heart failure, unstable angina pectoris, arrhythmias (excluding stable atrial fibrillation), and significant carotid stenosis.\n4. \\* Acute systemic infections, coagulation disorders or other serious cardiopulmonary diseases;\n5. Patients who have used large amounts of glucocorticoids or other immunosuppressants within 4 weeks;\n6. \\* A history of severe hypersensitivity to any of the drugs used in this study;\n7. Known uncontrolled central nervous system (CNS) metastases and\u002For cancerous meningitis;\n8. \\* Pregnant and lactating women, as well as women and men who were unable to cooperate with contraception during the study period;\n9. Previous anti-tumor therapy: within four weeks of radiotherapy, chemotherapy, one week after TKI inhibitor treatment, four weeks of investigational therapy or four half-lives, whichever is shorter;\n10. \\* Enroll in another clinical study at the same time, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study;\n11. \\* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n12. \\* Known history of interstitial lung disease. Exclude subjects with high suspicion of interstitial pneumonia; Or may interfere with the detection or management of suspected drug-related pulmonary toxicity; Or other moderate to severe lung diseases that seriously affect lung function;\n13. \\* Known history of primary immunodeficiency virus infection or positive HIV test;\n14. \\* Patients with chronic hepatitis B or HBV carriers of chronic hepatitis B virus (HBV), or patients with active hepatitis C should be excluded;\n15. \\* Any of the following cardiovascular diseases\n\n    1. have evidence of acute or persistent episodes of myocardial ischemia;\n    2. symptomatic pulmonary embolism is present;\n    3. acute myocardial infarction occurred within 6 months prior to the initial study treatment;\n    4. symptomatic congestive heart failure (grade 3 or 4 according to the New York Heart Association Functional Scale) occurred within 6 months prior to the first study treatment;\n    5. Occurrence of grade 2 or more ventricular arrhythmias within 6 months prior to the first study treatment;\n    6. cerebrovascular accident or transient ischemic stroke occurred within 6 months prior to the first study treatment\n16. \\* Subjects with pleural effusion, pericardial effusion, or ascites that, in the investigator\\'s judgment, cannot be stably controlled by repeated drainage or other methods;\n17. Have received a live vaccine within 30 days prior to the first dose or plan to receive a live vaccine during the study period;\n18. \\* Disease known to produce severe hypersensitivity to other monoclonal antibodies;\n19. Any condition that the investigator believes may result in a risk of acceptance of the study drug treatment or interfere with the evaluation of the study drug or the safety of the subjects or the interpretation of the study results;\n20. \\* With a second primary tumor (within 5 years).",{"count":58,"type":21},23,[24],"A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination of cell therapy and Serplulimab Injection.\n\nTo be more precise, the study aims to include patients who have been diagnosed with metastatic or locally advanced refractory\u002Frecurrent malignant solid tumors and have shown resistance to standard therapeutic interventions. These tumor types may encompass head and neck cancer, ovarian cancer, lung cancer, melanoma, and others.",[28,27,29],[32,33,63,36,34,35,29,30],"Tumor Associated Lymph node T cell","2024-11-29",{"date":66,"type":41},"2024-12-03",{"date":68,"type":41},"2023-06-06",{"date":70,"type":21},"2026-06-30",{"name":47,"class":48}]