[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tumor-infiltrating-lymphocytes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tumor-infiltrating-lymphocytes":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,66,90],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100579748","early-phase-1-a-study-of-gc203-til-in-pdca-rj-100579748",false,"NCT06828328","A Study of GC203 TIL in PDCA (RJ)","A Phase I Study of Engineered Tumor Infiltrating Lymphocytes Injection (GC203 TIL) in Patients With Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n1. have done the tumor resection for gene-edited GC203 TIL production and successfully produced；\n2. Age: 18 years to 70 years;\n3. Histologically diagnosed as pancreatic ductal adenocarcinoma;\n4. Expected life-span more than 3 months;\n5. ECOG score 0-1;\n6. Test subjects have failed standard treatment regimens, and be willing to recieve gene-edited GC203 TIL therapy;\n7. At least 1 evaluable tumor lesion;\n8. Hematology and Chemistry（within 7 days prior to enrollment）:\n\nAbsolute count of white blood cells≥2.5×10\\^9\u002FL; Absolute count of neutropils≥1.5×10\\^9\u002FL; Absolute count of lymphocytes ≥0.7×109\u002FL； Platelet count≥90×10\\^9； hemoglobin≥90 g\u002FL; Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin; Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN); Totol bilirubin≤1.5×ULN; 9.Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletion； 10.Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs; 12.Be able to understand and sign the informed consent document; 13.Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n1. with other malignant tumors,except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;\n2. Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n3. Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is \\\u003C 95%;\n4. Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;\n5. Significant cardiovascular anomalies according to any of the following definition:\n\n   New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.\n6. Uncontrolled metabolic disorders, such as diabetes, which is known to be uncontrolled, or other non-malignant organ or systemic disease or cancer secondary reactions, can lead to higher medical risk and\u002For uncertainty in the evaluation of survival;\n7. Patients with esophageal or gastric varices requiring immediate intervention (e.g., ligation or sclerotherapy) or who, in the opinion of the investigator or in consultation with a gastroenterologist or hepatologist, have evidence of portal hypertension (including splenomegalgia on imaging) or a history of varicose bleeding must undergo endoscopic evaluation within the first 3 months of enrollment;\n8. Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis, liver failure;\n9. Pulmonary fibrosis, interstitial lung disease (both past and present), acute lung disease;\n10. Clinically uncontrollable third space effusion, such as pleural fluid and ascites that could not be controlled by drainage or other means prior to enrollment;\n11. Patients with known pnelmeningeal metastases; Other patients known to have uncontrolled or untreated central nervous system metastases that are not effectively controlled by treatment, except those who have been treated and whose symptoms are stable, and who discontinue glucocorticoid and anticonvulsant therapy ≥4 weeks prior to cell retransfusion;\n12. Severe physical or mental diseases;\n13. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);\n14. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;\n15. History of allogeneic T cell therapy;\n16. Having received immunotherapy and developed irAE level greater than Level 3;\n17. Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded);\n18. Females in pregnancy or lactation;\n19. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;\n20. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.","ALL","18 Years","70 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This study is to investigate the safety and efficacy of gene-edited tumor infiltrating lymphocyte (GC203 TIL) therapy in patients with pancreatic ductal adenocarcinoma. Gene-edited TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.",[27,28,29,30],"Pancreatic Cancer","Pancratic Ductal Adenocarcinoma","Treatment Side Effects","Tumor Infiltrating Lymphocytes","RECRUITING","2025-12-16",{"date":34,"type":35},"2025-12-23","ACTUAL",{"date":37,"type":35},"2025-02-10",{"date":39,"type":21},"2028-01-31",{"name":41,"class":42},"Shanghai Juncell Therapeutics","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":43},"100553658","early-phase-1-a-study-of-til-in-advanced-solid-tumors-dfgd-100553658","NCT06488950","A Study of TIL in Advanced Solid Tumors (DFGD)","A Study Study of Tumor Infiltrating Lymphocytes Injection (GC101\u002F203 TIL) in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* have one the tumor resection for TILs production and successfully produced；\n* Age: 18 years to 75years;\n* Histologically diagnosed as solid tumors;\n* Expected life-span more than 3 months;\n* ECOG score 0-1;\n* Test subjects have failed standard treatment regimens, and be willing to receive TIL therapy;\n* At least 1 evaluable tumor lesion;\n\nExclusion Criteria:\n\n* with other malignant tumors, except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;\n* Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n* Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is \\\u003C 95%;\n* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;\n* Significant cardiovascular anomalies","75 Years",{"count":53,"type":21},30,[24],"This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.",[57,30,29,58],"Advanced Solid Tumor","Effects of Immunotherapy","2025-12-08",{"date":32,"type":35},{"date":62,"type":35},"2023-04-01",{"date":64,"type":21},"2027-06-30",{"name":41,"class":42},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":43},"100595634","phase-1-study-on-the-safety-and-tolerability-of-pd-1-knockout-tumor-infiltrating-t-cells-tils-in-the-treatment-of-advanced-colorectal-cancer-100595634","NCT07035002","Study on the Safety and Tolerability of PD-1 Knockout Tumor-infiltrating T Cells (TILs) in the Treatment of Advanced Colorectal Cancer","Inclusion Criteria:\n\n* Patients with advanced colorectal cancer confirmed by histology or cytology, who were not eligible to standard treatment at this stage.\n* Patients volunteered to receive surgery or biopsy to obtain tumor tissue for TILs preparation.\n* Aged ≥18 and ≤70 years old.\n* At least one tumor lesion that could be evaluated according to RECIST, version 1.1.\n* ECOG score was 0 or 1.\n* Adequate bone marrow and organ function.\n* The expected survival time of the enrolled patients was no less than 6 months.\n\nExclusion Criteria:\n\n* Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments within 2 weeks before sampling, except the following:\n\n  1. Nitrosourea or mitomycin C within 6 weeks before surgery;\n  2. Oral fluorouracils and small molecule targeted drugs for 1 week before surgery.\n* Received other unmarketed investigational drug or treatment within 4 weeks before sampling;\n* Had undergone major organ surgery (excluding needle biopsy) within 4 weeks before sampling or had significant lesions Trauma, or the need for elective surgery during the trial;\n* Received systemic glucocorticoid (prednisone \\>10mg\u002F day or equivalent dose) or other immunosuppressive therapy within 14 days before sampling; Treatment with topical, ocular, intra-articular, nasal, and inhaled glucocorticoids was excluded. Short-term prophylaxis with glucocorticoids (e.g., to prevent contrast allergy)\n* Use of immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferin, etc., within 14 days before sampling;\n* Administration of live attenuated vaccine within 4 weeks before sampling;\n* The toxicity of previous antineoplastic therapy has not recovered to CTCAE 5.0 grade ≤1 (except for alopecia and other researchers who judged that there was no safety risk);\n* Patients with symptomatic central nervous system or leptomeningeal metastases or other evidence of uncontrolled central nervous system or leptomeningeal metastases as judged by the investigator to be ineligible for enrollment;\n* Patients with active infection within 1 week before sampling and currently requiring systemic anti-infective treatment;\n* A history of immunodeficiency, including positive HIV antibody test;\n* Hepatitis B (HBsAg positive and\u002For hepatitis C (anti-HCV positive) and\u002For treponema pallidum antibody positive;\n* Patients with current interstitial lung disease;\n* Has a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  1. severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree II-III atrioventricular block, etc.\n  2. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before the first dose of dose.\n  3. New York Heart Association (NYHA) functional class ≥II or left ventricular ejection fraction (LVEF) \\\u003C50%, or structural heart disease at high risk as judged by other investigators;\n  4. clinically uncontrolled hypertension.\n* Patients with active or previous autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), excluding patients with clinically stable autoimmune thyroid diseases and well-controlled type I diabetes;\n* Received immunotherapy with grade ≥ 3 irAE;\n* Clinically uncontrollable serous cavity effusion, which was judged by the investigator as not suitable for enrollment;\n* Known alcohol or drug dependence;\n* Persons with mental disorders or poor compliance;\n* Pregnant or lactating women;",{"count":73,"type":21},29,[75],"PHASE1","TIL from tumor tissue of advanced colorectal cancer patients were cultured, modified and expanded in vitro, and then transfused back to the patients after quality control. The safety and efficacy of the treatment were investigated. The fundamental cause of oncogenesis lies in the accumulation of gene mutations. A large number of gene mutations in tumor cells lead to changes in the encoded amino acid sequence, resulting in the production of tumor-specific proteins. Human T cells recognize tumor-specific peptides (tumor neoantigens) that are presented on the MHC molecules on the surface of tumor cells, leading to T cell enrichment within the tumor. However, due to the immunosuppressive effect of tumors through various ways, the enriched T cells in tumors cannot effectively kill tumor cells. One of the most common examples is that tumors up-regulate the expression of immune checkpoint protein PD-L1, which binds to PD-1 on the surface of T cells and inhibits T cell function. Therefore, in this study, we will obtain tumor tissue via surgery resection or biopsy, and then isolate TIL cells in the tumor under GMP conditions, and further use gene editing technology to knockout PD-1, the obtained gene-edited T cells will have the characteristics of specific recognition of tumor cells, but not sensitive to the immunosuppressive function of tumor cells, so as to achieve the therapeutic effect on tumor patients.",[78,30,79],"Colorectal Cancer (CRC)","PD-1","2025-06-15",{"date":82,"type":35},"2025-06-24",{"date":84,"type":35},"2024-12-31",{"date":86,"type":21},"2026-12",{"name":88,"class":89},"Ruijin Hospital","OTHER",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":97,"minAge":17,"maxAge":51,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100450999","phase-1-efficacy-and-safety-of-tils-in-treatment-of-patients-with-advanced-or-metastatic-refractory-gynecological-cancer-100450999","NCT05152797","Efficacy and Safety of TILs in Treatment of Patients With Advanced or Metastatic Refractory Gynecological Cancer","Efficacy and Safety of Autologous Tumor-infiltrating Lymphocytes in Treatment of Patients With Advanced or Metastatic Refractory Gynecological Cancer: a Prospective Multicenter One-arm Phase Ⅱ Trial","Inclusion Criteria:\n\nParticipants eligible for inclusion in this study must meet all of the following criteria: Signed informed consent must be obtained prior to participation in the study.\n\n* Aged 18-75 years old at the time of consent\n* Participants are diagnosed with advanced or metastatic cervical cancer, ovarian cancer, endometrial cancer or breast cancer with radiology and pathology confirmation.\n* Failure of two or more Lines of Chemotherapy, or not amenable to curative treatment.\n* At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to extract TIL\n* At least one measurable target lesion, that can be accurately measured in at least one dimension with longest diameter ≥20 mm, as defined by RECIST v1.1\n* All the chemotherapy or radiotherapy targeting the malignant tumors must be discontinued at least 28 days prior to the tumor resection.\n* No serious abnormality of complete blood count and Cardiac, Liver, and Kidney function\n\nExclusion Criteria:\n\n* Participants who have received organ transplantation or prior cell transfer therapy\n* Any active autoimmune disease or history of autoimmune disease, or history of primary immunodeficiency.\n* Patients who are taking systemic steroid therapy\n* Patients with confirmed HIV infection, or other uncontrolled active viral infections, or serious system infections\n* Patients with serious complications of heart, lung, liver, kidney, not suitable for enrollment.\n* Patients with suspicious or confirmed brain metastases of any size and any number.\n* Suffered from any other malignancy within 5 years (except for fully treated in situ malignant such as breast cancer, bladder cancer, cutaneous basal cell carcinoma or squamous cell carcinoma)\n* Patients who are pregnant or breastfeeding\n* Any other conditions judged by the researcher will significantly increase the risk of participation.","FEMALE",{"count":99,"type":21},91,[75,101],"PHASE2","Prospective, multicenter, single-arm, open label, interventional basket trial to evaluate autologous tumor-infiltrating lymphocytes (TILs) infusion followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparation for the treatment of patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma.",[30],"NOT_YET_RECRUITING","2021-11-28",{"date":107,"type":35},"2021-12-10",{"date":109,"type":21},"2022-01-01",{"date":111,"type":21},"2026-12-31",{"name":113,"class":89},"Women's Hospital School Of Medicine Zhejiang University"]