[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangzhou FineImmune Biotechnology Co., LTD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":146},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,71,100,122],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100630851","phase-1-an-open-label-phase-i-clinical-trial-of-super-car-t-with-gpc3-positive-advanced-hepatocellular-carcinoma-100630851",false,"NCT07493044","An Open-Label, Phase I Clinical Trial of Super CAR-T With GPC3-Positive Advanced Hepatocellular Carcinoma","An Open-Label, Phase I Clinical Trial of GPC3-Targeted Chimeric Antigen Receptor Autologous T-Cell Injection (Super CAR-T) for the Treatment of Patients With Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form prior to participating in any trial-related activities;\n2. Be between 18 and 75 years of age; gender is not restricted;\n3. Diagnosed with hepatocellular carcinoma (HCC) based on histopathological or cytological examination: Patients classified as inoperable Stage IIa, IIb, IIIa, or IIIb according to the Chinese National Liver Cancer (CNLC) staging system, or Stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system, or Stage B patients who are inoperable or unsuitable for local treatment; Child-Pugh liver function score ≤ 7;\n4. Previous failure of or intolerance to at least two lines of standard systemic therapy;\n5. The subject must provide a tumor sample or biopsy specimen collected within the past 2 years that meets the requirements and tests positive for GPC3 expression via immunohistochemistry;\n6. At least one measurable lesion according to RECIST 1.1 criteria;\n7. ECOG performance status of 0-1;\n8. Expected survival of more than 3 months;\n9. Echocardiography showing a left ventricular ejection fraction (LVEF) ≥50%;\n10. Laboratory test results must meet at least the following criteria:\n\n    ANC ≥1.0×10⁹\u002FL; PLT ≥75×10⁹\u002FL; Hb ≥ 75 g\u002FL; Creatinine clearance ≥ 60 mL\u002Fmin; AST ≤ 5×ULN; ALT≤ 5×ULN; TBIL ≤ 3×ULN;\n11. If HBsAg-positive or HBcAb-positive, HBV-DNA must be ≤ 2000 IU\u002FmL;\n12. Women of childbearing potential must have a negative pregnancy test prior to receiving study treatment; they must agree to use effective contraception during treatment.\n\nExclusion Criteria:\n\n1. The subject has undergone major surgery within 2 weeks prior to apheresis, or is expected to undergo major surgery during the trial;\n2. The subject is allergic to any component of the drugs to be used in this study, including but not limited to cyclophosphamide, fludarabine, CAR-T products, or their excipients;\n3. Has not recovered from adverse reactions related to prior surgery or treatment to Grade ≤ 2; exceptions include alopecia, hyperpigmentation, and other conditions deemed by the investigator not to affect the subject's tolerability;\n4. Has a clinically significant central nervous system (CNS) disorder (e.g., epilepsy, severe cerebrovascular stenosis) or other diseases presenting with significant neurological symptoms (including psychiatric disorders);\n5. Received radiotherapy, systemic chemotherapy, or immune checkpoint inhibitors for the study disease within 2 weeks prior to apheresis; or received small-molecule targeted therapies such as sorafenib, regorafenib, or lenvatinib within 1 week prior to apheresis;\n6. Received systemic glucocorticoid therapy within 7 days prior to single-plasma donation; patients currently using or who have recently used inhaled or topical glucocorticoids, as well as those on physiological-dose replacement therapy, are eligible for enrollment;\n7. Any uncontrolled active infection, including but not limited to active tuberculosis or infectious diseases requiring systemic treatment;\n8. Known active autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, multiple sclerosis, and glomerulonephritis (patients with vitiligo are not excluded);\n9. History of organ transplantation, autologous\u002Fallogeneic stem cell transplantation, or renal replacement therapy;\n10. HCV antibody-positive with HCV RNA levels above the lower limit of detection; HIV antibody-positive; syphilis antibody-positive;\n11. Currently pregnant or breastfeeding, or planning to become pregnant during the study;\n12. Participants deemed by the investigator to be unable or unwilling to comply with the requirements of the study protocol.","ALL","18 Years","75 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.",[27,28],"Advanced Hepatocellular Carcinoma (HCC)","GPC3 Positive Hepatocellular Carcinoma",[30,31,32,33],"GPC3 CAR-T","Cell therapy","Immunotherapy","Hepatocellular Carcinoma","RECRUITING","2026-05-12",{"date":37,"type":38},"2026-05-14","ACTUAL",{"date":40,"type":38},"2026-03-27",{"date":42,"type":21},"2028-07-30",{"name":44,"class":45},"Guangzhou FineImmune Biotechnology Co., LTD.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":25,"conditions":56,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":46},"100588495","phase-1-an-open-label-phase-i-clinical-trial-of-super1-tcr-t-in-ny-eso-1-positive-patients-with-advanced-solid-tumors-100588495","NCT06942143","An Open-label, Phase I Clinical Trial of Super1 TCR-T in NY-ESO-1-positive Patients With Advanced Solid Tumors","An Open-label, Phase I Clinical Trial of Autologous T Cells Transduced With NY-ESO-1 Antigen-specific High-affinity T Cell Receptors in NY-ESO-1-positive Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Sign informed consent before conducting any trial-related activities;\n2. Age of 18-75 years old, male or female;\n3. Patients with first-line treatment failure;\n4. Measurable lesions according to RECIST1.1 criteria.\n5. During the trial screening period, the following two screening criteria must be met (by the sponsor) :\n\n   * HLA-A\\*02 positive;\n   * The positive rate of NYESO-1 immunohistochemical staining was ≥20%.\n6. ECOG score 0-1;\n7. The expected survival time is more than 3 months;\n8. Antineoplastic drugs and treatments were not allowed for 4 weeks before TCR-T cell infusion;\n9. Echocardiography showed left ventricular ejection fraction ≥50%;\n10. Laboratory test results should at least meet the following specified indicators:\n\n    * WBC ≥3.0×109\u002FL;\n    * Absolute neutrophil count (ANC) ≥1.5×109\u002FL;\n    * Absolute lymphocyte count (ALC) ≥1.0×109\u002FL;\n    * platelet (PLT) ≥75×109\u002FL;\n    * hemoglobin ≥10g\u002FdL (no blood transfusion in the past 7 days);\n    * Prothrombin time or INR≤1.5x upper limit of normal unless receiving anticoagulant therapy;\n    * Partial prothrombin time (APTT) ≤1.5x upper limit of normal time, unless receiving anticoagulant therapy;\n    * 24-hour creatinine clearance ≥60mL\u002F min;\n    * Aspartate aminotransferase (AST\u002FSGOT) ≤2.5×ULN;\n    * alanine aminotransferase (ALT\u002FSGPT) ≤2.5×ULN;\n    * Total bilirubin (TBIL) ≤1.5×ULN\n11. Negative pregnancy tests in women of childbearing potential prior to study treatment; Consent must be given to use effective contraception during treatment.\n12. During the whole period of the trial, I can regularly visit the enrolled research institutions for relevant testing, evaluation and management.\n\nExclusion Criteria:\n\n1. Patients who received major surgery, conventional chemotherapy, large area radiotherapy, immunotherapy or biological therapy within 4 weeks before entering the trial;\n2. Known to produce allergic reactions to any component of the trial treatment;\n3. no recovery from previous surgery or treatment-related adverse events to ≤ grade 2 CTCAE;\n4. Poorly controlled hypertension (systolic blood pressure \\> 160mmHg and\u002For diastolic blood pressure \\> 90mmHg) or clinically significant (e.g., active) cardio-cerebrovascular disease; Cerebrovascular accident (within 6 months before the signing of informed consent), myocardial infarction (within 6 months before the signing of informed consent), unstable angina, congestive heart failure of New York Heart Association class II or higher (Appendix), or severe arrhythmia that could not be controlled with medications or that had the potential to affect study treatment; Electrocardiogram (ECG) was significantly abnormal or the mean QTc interval was ≥450 msec on three consecutive occasions.\n5. Combined with other serious organic diseases and mental disorders;\n6. Have active systemic infection requiring treatment, including active tuberculosis, known HIV positivity, or clinically active hepatitis A, B, or C; (Virus carriers should be excluded)\n7. Patients with autoimmune diseases: those with a history of inflammatory bowel disease or a history of autoimmune diseases (such as systemic lupus erythematosus, vasculitis, and invasive lung disease) judged by the investigators to be not suitable for this study should be excluded; (Patients with vitiligo are not excluded).\n8. Administration of chronic systemic cortisone steroids, hydroxyurea, and immunomodulatory agents (e.g., interleukin-2, interferon-α or γ, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.) within 4 weeks prior to cell therapy.\"\n9. History of organ transplantation, autologous\u002Fallogeneic stem cell transplantation and renal replacement therapy;\n10. Known uncontrolled diabetes mellitus, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure;\n11. Known alcohol and\u002For drug abuse;\n12. Pregnant or lactating women;\n13. Trial participants with any coexisting medical conditions or diseases judged by the investigators to be likely to impair the conduct of the trial;\n14. No legal capacity\u002Flimited capacity.",{"count":20,"type":21},[24],[57,58,59],"Sarcoma","Lung Cancers","Melanoma",[31,32,61,62],"Solid tumor","NY-ESO-1 TCR-T","2025-08-26",{"date":65,"type":38},"2025-09-03",{"date":67,"type":38},"2025-05-22",{"date":69,"type":21},"2027-06-25",{"name":44,"class":45},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":46},"100571159","phase-1-a-phase-i-trial-of-tumor-associated-lymph-node-t-cell-injection-with-advanced-malignant-solid-tumors-100571159","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.",{"count":79,"type":21},32,[24],"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.",[83,84,32,85],"Tumor Associated Lymph Node T Cell","Advanced Solid Tumor","Serplulimab Injection",[32,84,83,87,88,85,89,90,91],"TAL-T","cell therapy","Adverse Drug Event","Efficacy","Safety","2025-03-24",{"date":94,"type":38},"2025-03-26",{"date":96,"type":38},"2025-02-13",{"date":98,"type":21},"2027-12-19",{"name":44,"class":45},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":87,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":46},"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":108,"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.",[84,83,32],[87,88,113,91,89,90,32,85],"Tumor Associated Lymph node T cell","2024-11-29",{"date":116,"type":38},"2024-12-03",{"date":118,"type":38},"2023-06-06",{"date":120,"type":21},"2026-06-30",{"name":44,"class":45},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":46},"100354192","phase-1-individualized-tumor-specific-tcr--t-cells-in-the-treatment-of-advanced-solid-tumors-100354192","NCT03891706","Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors","An Open, Single-center, Stage I Clinical Study of Individualized Tumor Specific TCR-T Cells in the Treatment of Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Aged between 18 and 70 years old, regardless of gender;\n2. Diagnosed as solid tumors by histopathology, and the tumor lesions could be detected or evaluated;\n3. Be after standard treatment or who lack effective treatment programs;\n4. Patients and their families were willing to participate in the clinical trial and signed the informed consent;\n5. Physical status: ECOG score 0-1;\n6. Expected survival time \\> 3 months;\n7. HIV antibody negative;Hepatitis b surface antigen negative;Hepatitis c antibody negative;The results of blood routine and coagulation were roughly normal, lymphocyte \\>0.8×10\\^9\u002FL, hemoglobin \\>100g\u002FL, and the pregnancy test of female patients with fertility potential was negative.\n8. Left ventricular ejection fraction 50% as indicated by cardiac ultrasound;Upper normal level of serum ALT\u002FAST \\\u003C 2.5 times;Serum creatinine 1.6mg\u002Fdl;Total bilirubin 1.5mg\u002Fdl, subject's total bilirubin \\\u003C 3mg\u002Fdl except for Gilberts Syndrome;\n9. At least 4 weeks after the last systemic treatment, the patient's toxic and side effects must be restored to grade 1 or lower (except for alopecia or vitiligo).If the subject undergoes minor surgery within 3 weeks prior to enrollment, as long as all toxicity is recovered to level 1 or lower, the subject will meet the enrollment requirements.\n10. During the whole study period, patients can regularly visit the enrolled research institutions for relevant detection, evaluation and management;\n11. The patient is not allowed to use any anti-tumor drugs or treatments for 4 weeks prior to the infusion of TCR-T cells;\n12. Patients' tumor lesions can be obtained by surgery or puncture, and tumor infiltrating T cells can be successfully isolated from the obtained tumor tissue;\n13. T cells in patients' peripheral blood can effectively proliferate and expand by at least 10 times in the Pre-culture;\n14. The benefits of participating in the clinical trial outweigh the risks,which was evaluated by the researchers base on the status or condition of the patients.\n\nExclusion Criteria:\n\n1. Any form of primary immunodeficiency disease (such as severe combined immunodeficiency disease);\n2. Experiencing moderate to severe infection or possible opportunistic infection;\n3. Patients with a history of autoimmunity (e.g., SLE, psoriasis, etc.);\n4. Acute systemic infection, coagulation dysfunction or other serious cardiopulmonary diseases;\n5. Patients who have is suffering a large amount of glucocorticoid or other immunosuppressive agents within 4 weeks;\n6. Be allergic to any drug used in this study;\n7. Central nervous system metastases patients with clinically unstable or acute meningitis (except these clinically stable after treatment) Clinical stability needs to be met as follows: 4 weeks at least before the trial treatment, 1) no new brain lesion or no expanded of the original lesions confirmed by MRI); 2) no hormone therapy for at least 2 weeks; 3) neurological symptoms have returned to baseline;\n8. Pregnant and lactating women, as well as male and female patients who could not cooperate with contraception during the study period.","70 Years",{"count":131,"type":21},30,[24],"The primary purpose of this study is to evaluate the safety of the tumor-specific TCR-T cells in the treatment of advanced Solid Tumor .\n\nThe secondary purpose of this study is to preliminarily showed the effect of TCR-T cells in the treatment of advanced Solid Tumor .",[135],"Solid Tumor",[137],"TCR-T","2024-09-13",{"date":140,"type":38},"2024-09-19",{"date":142,"type":38},"2019-01-08",{"date":144,"type":21},"2025-12-31",{"name":44,"class":45},""]