[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Juncell Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":329},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,40,63,85,109,132,151,169,191,217,236,256,272,291,311],{"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":4},"100636009","phase-2-a-phase-ii-study-of-gc101-in-nsclc-100636009",false,"NCT07560111","A Phase II Study of GC101 in NSCLC","An Open-Label, Phase II Study to Evaluate the Safety and Efficacy Using Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* 1\\. Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;\n* 2\\. Aged ≥18 years and ≤70 years, regardless of gender;\n* 3.Patients with non-small cell lung cancer who have been confirmed negative for EGFR mutations, ALK, and ROS-1 by prior genetic testing, meeting one of the following criteria:(1) If the patient is known to carry one or more other actionable genetic mutations (e.g., KRAS G12C mutation, BRAF V600 mutation, MET exon 14 skipping mutation, HER-2 mutation, RET fusion, NTRK fusion), the patient must have received at least one approved targeted therapy, and the investigator considers that additional targeted therapy would not be in the best interest of the study participant. In addition, the patient must have experienced failure of platinum-based chemotherapy.\n* 4\\. TILs can be isolated from a surgically resectable tumor region: the tissue volume must be \\>150mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or progressed after local treatment;\n* 5\\. There are still at least 1 measurable lesion (according to RECIST1.1 criteria \\[see Appendix 4\\]) even after TIL sampling and resection of surgically resectable tissue;\n* 6\\. ECOG performance status 0-1;\n* 7\\. Expected survival time \\>3 months;\n* 8\\. With sufficient hematology and end-organ function\n* 9.\\* Premenopausal women who have not undergone sterilization surgery must agree to use effective contraception measures from the start of study treatment (preconditioning) to one year after cell infusion, and the serum pregnancy test during the screening period must be negative; \\*Men who have not undergone sterilization surgery must agree to use effective contraception measures from the start of study treatment (preconditioning) until one year after cell infusion;\n* 10\\. No absolute or relative contraindications for surgery;\n* 11\\. Any melanoma treatment methods, including radiotherapy, chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization, or traditional Chinese medicine\u002Fherbal medicine treatment with anti-tumor indications, must be stopped 28 days before infusion. If a small molecular targeted drug was used in the previous treatment, the withdrawal time can be shortened to 5 half-lives of the drug used;\n* 12\\. Good compliance and able to adhere to the study visit plan and other agreement requirements.\n\nExclusion Criteria:\n\n* 1\\. Participation in a clinical trial of another drug or biologic therapy or receipt of a comparable cellular therapy within 28 days prior to infusion;\n* 2\\. Combination of 2 or more malignant tumors, except: Eradicated malignant tumors that have been inactive for ≥5 years prior to study entry and are at minimal risk of recurrence; adequately treated non-melanoma skin cancer or malignant nevus of freckle-like nevus without evidence of disease recurrence; adequately treated carcinoma in situ without evidence of disease recurrence;\n* 3.Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study;\n* 4.Has not recovered from a prior procedure or treatment-related adverse reaction to ≤ grade 1 nci ctcae 5.0 (except for toxicities such as alopecia, etc., which in the judgment of the investigator pose no safety risk);\n* 5\\. Known history of allergy to streptomycin, ciprofloxacin, or micafungin or allergy to any component of the infused product formulation;\n* 6.Uncontrolled co-morbidities including, but not limited to, uncontrolled arterial hypertension (systolic blood pressure ≥160 mmhg and\u002For diastolic blood pressure ≥100 mmhg) even with standardized treatment or any unstable cardiovascular disease including transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina pectoris within 6 months prior to enrollment; new york heart association ( nyha class iii or iv congestive heart failure with an ejection fraction \\\u003C50%; or severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias, degree ii-iii atrioventricular block, etc., requiring clinical intervention; ecg results showing clinically significant abnormalities or a qtcf ≥450ms (if the first test is abnormal, it may be retested at least 5 minutes apart twice and the combined result\u002Fmean value to determine eligibility) ;\n* 7.Patients with esophageal or gastric varices that require immediate intervention (e.g., taping or sclerotherapy) or are considered to be at high risk for bleeding based on the opinion of the investigator or consultation with a gastroenterologist or hepatologist, have evidence of portal hypertension (including splenomegaly detected on imaging), or have a prior history of variceal bleeding must have undergone endoscopic evaluation within 3 months prior to enrollment;\n* 8.Uncontrolled metabolic disorders, such as diabetes mellitus known to be uncontrolled, or other non-malignant organ or systemic diseases or secondary reactions to cancer, and which can lead to higher medical risk and\u002For uncertainty in survival evaluation;\n* 9.Hepatic encephalopathy, hepatorenal syndrome or child-pugh class b or more severe cirrhosis, liver failure;\n* 10.Comorbidity with other serious organic or psychiatric disease;\n* 11.Have an active systemic infection requiring treatment with positive blood cultures or imaging evidence of infection, including but not limited to active tuberculosis;\n* 12.Be hiv-positive, have a positive serologic test for syphilis, or have clinically active hepatitis a, b, or c, including viral carriers: Hepatitis b, excluding those who are HBsAg-positive; hepatitis c, excluding those who are HCVAb-positive;\n* 13.Active autoimmune diseases that still require systemic steroid hormones or other immunosuppressive drugs during the screening period (greater than 10 mg\u002F day of prednisone or equivalent doses of other hormones);\n* 14.Any nci ctcae5.0 immune-related adverse effect (irae) grade ≥ 3 during any prior period of immunotherapy receipt;\n* 15.History of organ allograft, allogeneic stem cell transplantation and renal replacement therapy; History of allogeneic t-cell and nk-cell therapy;\n* 16\\. Pulmonary fibrosis, interstitial lung disease (both past history and current), and acute lung disease; Patients with obstructive or restrictive lung disease with FEV1(forced expiratory volume in 1 second) of lung function ≤70%;\n* 17.Clinically uncontrollable third space effusions, such as pleural and abdominal effusions that cannot be controlled by drainage or other means prior to enrollment;\n* 18.Patients with clinically symptomatic central nervous system metastases (e.g., cerebral edema, need for hormonal intervention, or progression of brain metastases). Patients with prior treatment for brain metastases, such as clinical stability (mri) that has been maintained for at least 2 months and who have discontinued systemic hormone therapy (dose \\>10 mg\u002Fday prednisone or other equipotent hormone) for \\>4 weeks may be included;\n* 19.Women who are pregnant or breastfeeding;\n* 20.If the investigator believes that other circumstances are not suitable for enrollment.","ALL","18 Years","70 Years",{"count":20,"type":21},28,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","28 participants are expected to be enrolled for the Phase II clinical trial, this trial is expected to be finished in 36 months.",[27],"Non Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-04-24",{"date":31,"type":32},"2026-04-30","ACTUAL",{"date":34,"type":21},"2026-06-01",{"date":36,"type":21},"2029-06-01",{"name":38,"class":39},"Shanghai Juncell Therapeutics","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100615612","phase-1-a-study-of-til-in-advanced-solid-tumors-cz-100615612","NCT07294872","A Study of TIL in Advanced Solid Tumors (CZ)","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",{"count":48,"type":21},30,[50],"PHASE1","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 and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.",[53],"Solid Tumor, Adult","2026-01-15",{"date":56,"type":32},"2026-01-16",{"date":58,"type":21},"2026-05-08",{"date":60,"type":21},"2029-09-20",{"name":38,"class":39},1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100612682","phase-1-a-study-of-gc203-til-in-advanced-solid-tumors-nf-100612682","NCT07256756","A Study of GC203 TIL in Advanced Solid Tumors (NF)","A Phase I Study of Engineered Tumor Infiltrating Lymphocytes Injection (GC203 TIL) in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* have one the tumor resection for gene-edited GC203 TIL production and successfully produced；\n* Age: 18 years to 75years;\n* Histologically diagnosed as solid tumor;\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 engineered GC203 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":72,"type":21},8,[50],"This study is a prospective, open-label, single-arm clinical trial aimed at evaluating the safety and efficacy of GC203 TIL therapy in treating malignant solid tumors that have failed standard treatment.",[76],"Solid Tumors, Adult","2025-12-16",{"date":79,"type":32},"2025-12-23",{"date":81,"type":21},"2026-01-30",{"date":83,"type":21},"2028-11-30",{"name":38,"class":39},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":62},"100579748","early-phase-1-a-study-of-gc203-til-in-pdca-rj-100579748","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.",{"count":93,"type":21},10,[95],"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.",[98,99,100,101],"Pancreatic Cancer","Pancratic Ductal Adenocarcinoma","Treatment Side Effects","Tumor Infiltrating Lymphocytes","RECRUITING",{"date":79,"type":32},{"date":105,"type":32},"2025-02-10",{"date":107,"type":21},"2028-01-31",{"name":38,"class":39},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":62},"100570142","phase-2-a-study-of-gc101-til-in-advanced-melanoma-100570142","NCT06703398","A Study of GC101 TIL in Advanced Melanoma","A Multicenter, Randomized, Controlled,Open Label, Phase II Trial of Autologous Tumor Infiltrating Lymphocytes (GC101 TIL) in Subjects With Advanced Melanoma","MIZAR-003","Inclusion Criteria:\n\n* Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;\n* Aged ≥18 years and ≤75 years, regardless of gender;\n* Patients with unresectable advanced, recurrent or metastatic melanoma (excluding uveal melanoma) ;\n* Patients who have failed or resisted to PD-1 antibodies；\n* Patients must have failed or resisted to at least two frontlines systemic tehrapy(if knowed with BRAF V600 mutate, then need to failed to BRAF\u002FMEK inhibitor; if knowed with NRAS mutate, then need to failed to Tunlametinib) ；\n* TILs can be isolated from a surgically resectable tumor region: the tissue volume must be \\>150mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or progressed after local treatment;There are still at least 1 measurable lesion (according to RECIST1.1 criteria ) even after TIL sampling and resection of surgically resectable tissue;\n* ECOG performance status 0-1;\n* Expected survival time \\>3 months;\n* With sufficient hematology and end-organ function;\n* Good compliance and able to adhere to the study visit plan and other agreement requirements.\n\nExclusion Criteria:\n\n* Patients receive any drug under study within 28 days prior to screening;\n* Combination of 2 or more malignant tumors, except: Eradicated malignant tumors that have been inactive for ≥5 years prior to study entry and are at minimal risk of recurrence; adequately treated non-melanoma skin cancer or malignant nevus of freckle-like nevus without evidence of disease recurrence; adequately treated carcinoma in situ without evidence of disease recurrence;\n* Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study;\n* Has not recovered from a prior procedure or treatment-related adverse reaction to ≤ grade 1 nci ctcae 5.0 (except for toxicities such as alopecia, hypothyroidism etc., which in the judgment of the investigator pose no safety risk);\n* Known history of allergy to streptomycin, ciprofloxacin, or micafungin or allergy to any component of the infused product formulation;\n* Uncontrolled co-morbidities including, but not limited to, uncontrolled arterial hypertension (systolic blood pressure ≥160 mmhg and\u002For diastolic blood pressure ≥100 mmhg) even with standardized treatment or any unstable cardiovascular disease including transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina pectoris within 6 months prior to enrollment; new york heart association ( nyha class iii or iv congestive heart failure with an ejection fraction \\\u003C50%; or severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias, degree ii-iii atrioventricular block, etc., requiring clinical intervention; ecg results showing clinically significant abnormalities or a qtcf ≥450ms (if the first test is abnormal, it may be retested at least 5 minutes apart twice and the combined result\u002Fmean value to determine eligibility) ;\n* Patients with esophageal or gastric varices that require immediate intervention (e.g., taping or sclerotherapy) or are considered to be at high risk for bleeding based on the opinion of the investigator or consultation with a gastroenterologist or hepatologist, have evidence of portal hypertension (including splenomegaly detected on imaging), or have a prior history of variceal bleeding must have undergone endoscopic evaluation within 3 months prior to enrollment;\n* Uncontrolled metabolic disorders, such as diabetes mellitus known to be uncontrolled, or other non-malignant organ or systemic diseases or secondary reactions to cancer, and which can lead to higher medical risk and\u002For uncertainty in survival evaluation;\n* Hepatic encephalopathy, hepatorenal syndrome or child-pugh class b or more severe cirrhosis, liver failure;\n* With other serious organic diseases or mental disorders;\n* Suffering from systemic active infection requiring treatment, with positive blood culture or imaging evidence of infection, including but not limited to active tuberculosis;\n* Suffering from infectious diseases such as hepatitis B, hepatitis C, syphilis, AIDS, etc;\n* Individuals with active autoimmune diseases (such as eczema, vitiligo, psoriasis, alopecia or Graves' disease that do not require systemic treatment within the past two years, other autoimmune diseases that are not expected to recur, hypothyroidism that only requires thyroid hormone replacement therapy, and type 1 diabetes that only requires insulin replacement therapy can be enrolled);\n* Any NCI CTCAE 5.0 immune-related adverse reaction (iRAE) grade ≥3 occurred during any previous immunotherapy(except for cases where it recovered to ≤1 after treatment or reached stability as assessed by the investigator);\n* Those who had undergone organ allotransplantation, allogeneic stem cell transplantation and renal replacement therapy;\n* Pulmonary fibrosis, interstitial lung disease (including past history and current condition), acute lung disease;\n* Those with leptomeningeal metastasis;\n* Patients with clinical symptoms of central nervous system metastases (such as cerebral edema, requiring hormone intervention, or progression of brain metastases), Patients who have previously received treatment for brain metastases, such as those who have maintained clinical stability (MRI) for at least 2 months and have stopped systemic hormone therapy (dose \\> 10mg\u002F day prednisone or other equivalent hormones) for more than 4 weeks, can be included;\n* Women who are pregnant or breastfeeding;\n* There is a history of TIL cell therapy, allogeneic T cell therapy, or NK cell therapy within 6 months;\n* Situations that are not suitable for enrollment assesed by investigators;",{"count":118,"type":21},98,[24],"98 participants will be randomly assigned 1:1 to the experimental group and the control group for the Phase II clinical trial，this trail is expected to be finished in 24 months",[122],"Melanoma",[124,101,125],"Randomized-controlled trial","Chemotherapy",{"date":79,"type":32},{"date":128,"type":32},"2024-12-20",{"date":130,"type":21},"2026-12-20",{"name":38,"class":39},{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":62},"100436195","early-phase-1-a-study-of-gc101-til-in-rr-gastrointestinal-tumors-10hospital-100436195","NCT04960072","A Study of GC101 TIL in r\u002Fr Gastrointestinal Tumors (10hospital)","A Clinical Safety and Efficacy Study of Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With r\u002Fr Gastrointestinal Tumors","Inclusion Criteria:\n\n1. Age: 18 years to 75 years;\n2. Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized gastrointestinal tumors ;\n3. Expected life-span more than 3 months;\n4. Karnofsky≥60% or ECOG score 0-2;\n5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;\n7. At least 1 evaluable tumor lesion;\n8. Hematology and Chemistry（within 7 days prior to enrollment）:\n\n   * Absolute count of white blood cells≥2.5×10\\^9\u002FL;\n   * Absolute count of neutropils≥1.5×10\\^9\u002FL;\n   * Absolute count of lymphocytes ≥0.7×109\u002FL；\n   * Platelet count≥100×10\\^9；\n   * hemoglobin≥90 g\u002FL;\n   * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin;\n   * Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN);\n   * Totol bilirubin≤1.5×ULN;\n9. no absolute or relative contraindications to operation or biopsy;\n10. 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；\n11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;\n12. Be able to understand and sign the informed consent document;\n13. Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;\n3. Significant cardiovascular anomalies according to any of the following definition: 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.\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. Severe physical or mental diseases;\n6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);\n7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;\n8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;\n9. Having received immunotherapy and developed irAE level greater than Level 3;\n10. 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);\n11. Females in pregnancy or lactation;\n12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;\n13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.",{"count":140,"type":21},50,[95],"This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant refractory\u002Frelapsed gastrointestinal tumors. Autologous 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.",[144],"Gastrointestinal Tumor",{"date":79,"type":32},{"date":147,"type":32},"2021-06-30",{"date":149,"type":21},"2026-07-30",{"name":38,"class":39},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":62},"100553658","early-phase-1-a-study-of-til-in-advanced-solid-tumors-dfgd-100553658","NCT06488950","A Study of TIL in Advanced Solid Tumors (DFGD)",{"count":48,"type":21},[95],"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.",[160,101,100,161],"Advanced Solid Tumor","Effects of Immunotherapy","2025-12-08",{"date":77,"type":32},{"date":165,"type":32},"2023-04-01",{"date":167,"type":21},"2027-06-30",{"name":38,"class":39},{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":62},"100552505","phase-1-a-phase-ib-study-of-gc101-in-nsclc-100552505","NCT06473961","A Phase Ib Study of GC101 in NSCLC","An Open, Single-armed, Phase Ib Study to Evaluate the Safety and Efficacy Using Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Non-Small Cell Lung Cancer","MIZAR-005","Inclusion Criteria:\n\n* 1\\. Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;\n* 2\\. Aged ≥18 years and ≤70 years, regardless of gender;\n* 3\\. Patients with unresectable advanced, recurrent, or metastatic non-small cell lung cancer who are positive for driver genes and have failed after targeted and platinum-containing dual chemotherapy;\n* 4\\. TILs can be isolated from a surgically resectable tumor region: the tissue volume must be \\>150mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or progressed after local treatment;\n* 5\\. There are still at least 1 measurable lesion (according to RECIST1.1 criteria \\[see Appendix 4\\]) even after TIL sampling and resection of surgically resectable tissue;\n* 6\\. ECOG performance status 0-1;\n* 7\\. Expected survival time \\>3 months;\n* 8\\. With sufficient hematology and end-organ function as defined by the following laboratory test results, the test results must be completed and issued within 7 days before tumor tissue collection:\n\n  * White Blood Cell (WBC)≥2.5×10\\^9\u002FL#\n  * Absolute Lymphocyte Count (ANC)≥1.5×10\\^9\u002FL;\n  * Absolute Lymphocyte Count(ALC)≥0.7×10\\^9\u002FL;\n  * Platelet≥100×10\\^9\u002FL#\n  * International Normalized Ratio#INR#≤1.5×ULN;\n  * Activated Partial Thromboplastin Time#APTT#≤1.5×ULN;\n  * Serum Creatinine (Scr)≤1.5mg\u002FdL (or 132.6μmol\u002FL) or Creatinine\n  * Clearance≥60mL\u002Fmin\n  * Urinalysis: urine protein less than 2+, or 24-hour urine protein \\\u003C1g;\n  * Alanine aminotransferase(AST\u002FSGOT) ≤3×ULN;\n  * Alanine aminotransferase (ALT\u002FSGPT) ≤3×ULN;\n  * Total Bilirubin(TBIL)≤1.5×ULN#\n* 9\\. \\* Premenopausal women who have not undergone sterilization surgery must agree to use effective contraception measures from the start of study treatment (preconditioning) to one year after cell infusion, and the serum pregnancy test during the screening period must be negative; \\*Men who have not undergone sterilization surgery must agree to use effective contraception measures from the start of study treatment (preconditioning) until one year after cell infusion;\n* 10\\. No absolute or relative contraindications for surgery;\n* 11\\. Any melanoma treatment methods, including radiotherapy, chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization, or traditional Chinese medicine\u002Fherbal medicine treatment with anti-tumor indications, must be stopped 28 days before infusion. If a small molecular targeted drug was used in the previous treatment, the withdrawal time can be shortened to 5 half-lives of the drug used;\n* 12\\. Good compliance and able to adhere to the study visit plan and other agreement requirements.\n\nExclusion Criteria:\n\n* 1\\. More than 5-line system therapy had been used in previous 3 years before screening period.\n* 2\\. Participation in a clinical trial of another drug or biologic therapy or receipt of a comparable cellular therapy within 28 days prior to infusion;\n* 3\\. Combination of 2 or more malignant tumors, except: Eradicated malignant tumors that have been inactive for ≥5 years prior to study entry and are at minimal risk of recurrence; adequately treated non-melanoma skin cancer or malignant nevus of freckle-like nevus without evidence of disease recurrence; adequately treated carcinoma in situ without evidence of disease recurrence;\n* 4\\. Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study;\n* 5\\. Has not recovered from a prior procedure or treatment-related adverse reaction to ≤ grade 1 nci ctcae 5.0 (except for toxicities such as alopecia, etc., which in the judgment of the investigator pose no safety risk);\n* 6\\. Known history of allergy to streptomycin, ciprofloxacin, or micafungin or allergy to any component of the infused product formulation;\n* 7\\. Uncontrolled co-morbidities including, but not limited to, uncontrolled arterial hypertension (systolic blood pressure ≥160 mmhg and\u002For diastolic blood pressure ≥100 mmhg) even with standardized treatment or any unstable cardiovascular disease including transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina pectoris within 6 months prior to enrollment; new york heart association ( nyha class iii or iv congestive heart failure with an ejection fraction \\\u003C50%; or severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias, degree ii-iii atrioventricular block, etc., requiring clinical intervention; ecg results showing clinically significant abnormalities or a qtcf ≥450ms (if the first test is abnormal, it may be retested at least 5 minutes apart twice and the combined result\u002Fmean value to determine eligibility) ;\n* 8\\. Patients with esophageal or gastric varices that require immediate intervention (e.g., taping or sclerotherapy) or are considered to be at high risk for bleeding based on the opinion of the investigator or consultation with a gastroenterologist or hepatologist, have evidence of portal hypertension (including splenomegaly detected on imaging), or have a prior history of variceal bleeding must have undergone endoscopic evaluation within 3 months prior to enrollment;\n* 9\\. Uncontrolled metabolic disorders, such as diabetes mellitus known to be uncontrolled, or other non-malignant organ or systemic diseases or secondary reactions to cancer, and which can lead to higher medical risk and\u002For uncertainty in survival evaluation;\n* 10\\. Hepatic encephalopathy, hepatorenal syndrome or child-pugh class b or more severe cirrhosis, liver failure;\n* 11\\. Comorbidity with other serious organic or psychiatric disease;\n* 12\\. Have an active systemic infection requiring treatment with positive blood cultures or imaging evidence of infection, including but not limited to active tuberculosis;\n* 13\\. Be hiv-positive, have a positive serologic test for syphilis, or have clinically active hepatitis a, b, or c, including viral carriers: Hepatitis b, excluding those who are HBsAg-positive; hepatitis c, excluding those who are HCVAb-positive;\n* 14\\. Active autoimmune diseases that still require systemic steroid hormones or other immunosuppressive drugs during the screening period (greater than 10 mg\u002F day of prednisone or equivalent doses of other hormones);\n* 15\\. Any nci ctcae5.0 immune-related adverse effect (irae) grade ≥ 3 during any prior period of immunotherapy receipt;\n* 16\\. History of organ allograft, allogeneic stem cell transplantation and renal replacement therapy; History of allogeneic t-cell and nk-cell therapy;\n* 17\\. Pulmonary fibrosis, interstitial lung disease (both past history and current), and acute lung disease; Patients with obstructive or restrictive lung disease with FEV1(forced expiratory volume in 1 second) of lung function ≤70%;\n* 18\\. Clinically uncontrollable third space effusions, such as pleural and abdominal effusions that cannot be controlled by drainage or other means prior to enrollment;\n* 19\\. Patients with clinically symptomatic central nervous system metastases (e.g., cerebral edema, need for hormonal intervention, or progression of brain metastases). Patients with prior treatment for brain metastases, such as clinical stability (mri) that has been maintained for at least 2 months and who have discontinued systemic hormone therapy (dose \\>10 mg\u002Fday prednisone or other equipotent hormone) for \\>4 weeks may be included;\n* 20\\. Women who are pregnant or breastfeeding;\n* 21\\. If the investigator believes that other circumstances are not suitable for enrollment.",{"count":178,"type":21},20,[50],"20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 36 months.",[182,27],"Non Small Cell Lung Cancer Metastatic","2025-12-04",{"date":185,"type":32},"2025-12-11",{"date":187,"type":32},"2024-10-14",{"date":189,"type":21},"2027-07-01",{"name":38,"class":39},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":209,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":62},"100544922","phase-1-a-study-of-gc203-til-in-advanced-malignant-solid-tumors-100544922","NCT06375187","A Study of GC203 TIL in Advanced Malignant Solid Tumors","A Phase I Study to Evaluate the Safety and Efficacy of Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL)in Patients With Advanced Malignant Solid Tumors","KUNLUN-001","Inclusion Criteria:\n\n* 1\\. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures.\n\n  2\\. Patients must be ≥18 and ≤75 years of age at the time of consent. 3. Patients with advanced metastatic solid tumors with clear pathological diagnosis have failed standard therapy (standard therapy is defined as existing guidelines and consensus recommended therapy \\[including but not limited to chemotherapeutic therapy, radiotherapy, mutation-targeted therapy, immunotherapy, and surgery\\]) , including but not limited to gynecological tumors (ovarian cancer, endometrial cancer, cervical cancer), breast cancer, gastrointestinal Cancer, lung cancer.\n\n  4\\. Patients have feasible tissue areas for tumor resection\u002Fpuncture to generate GC203 TIL, the total volume of the tissue \\> 400mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency therapy, oncolytic virus, etc.) or has progressed after local treatment; 5. At least one measurable target lesion before preconditioning, as defined by RECIST1.1.\n\n  6\\. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\n  7\\. Patients must have an estimated life expectancy of ≥3 months. 8. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function:\n  * Absolute Neutrophil Count (ANC)≥1.0×10\\^9\u002FL;\n  * Absolute Lymphocyte Count(ALC)≥0.5×10\\^9\u002FL;\n  * Platelet≥80×10\\^9\u002FL；\n  * International Normalized Ratio（INR）≤1.5×ULN;\n  * Activated Partial Thromboplastin Time（APTT）≤1.5×ULN;\n  * Serum Creatinine (Scr)≤1.5mg\u002FdL (or 132.6μmol\u002FL) or Creatinine Clearance≥60mL\u002Fmin\n  * Urinalysis: urine protein less than 2+, or 24-hour urine protein \\\u003C1g;\n  * Alanine aminotransferase(AST\u002FSGOT) ≤3×ULN;\n  * Alanine aminotransferase (ALT\u002FSGPT) ≤3×ULN;\n  * Total Bilirubin(TBIL)≤1.5×ULN； 9. Women of child-bearing potential (WCBP), must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.\n\n    10\\. Patients must have no contraindications for surgery or biopsy. 11. Patients have good compliance and be able to adhere to research access plans and other protocol requirements.\n\nExclusion Criteria:\n\n1. Participate in clinical trials of other drugs or biologic therapies within 4 weeks before enrollment;\n2. Participants who have had a history of allogeneic T cell therapy; gene engineering autologous cell therapy within 1 years.\n3. Patients who have received systemic antitumor therapy within 4 weeks.\n4. Patients who have had another primary malignancy within the previous 5 years\n5. Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment\n6. Patients with a history of hypersensitivity to any component of the study drugs\n7. Patients who are pregnant or breastfeeding.",{"count":200,"type":21},18,[50],"A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors",[204,205,206,207,208],"Solid Tumor","Gynecologic Cancer","Breast Cancer","Gastrointestinal Cancer","Lung Cancer",[210,101],"Adoptive cell therapy",{"date":185,"type":32},{"date":213,"type":32},"2024-05-29",{"date":215,"type":21},"2027-05-01",{"name":38,"class":39},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":62},"100450206","early-phase-1-a-study-of-gc101-til-in-advanced-breast-cancer-10hospital-100450206","NCT05142475","A Study of GC101 TIL in Advanced Breast Cancer (10hospital)","A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Breast Cancer","Inclusion Criteria:\n\n1. Age: 18 years to 75 years;\n2. Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized breast cancer;\n3. Expected life-span more than 3 months;\n4. Karnofsky≥60% or ECOG score 0-2;\n5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;\n7. At least 1 evaluable tumor lesion;\n8. Hematology and Chemistry（within 7 days prior to enrollment）:\n\n   * Absolute count of white blood cells≥2.5×10\\^9\u002FL;\n   * Absolute count of neutropils≥1.5×10\\^9\u002FL;\n   * Absolute count of lymphocytes ≥0.7×109\u002FL；\n   * Platelet count≥100×10\\^9；\n   * hemoglobin≥90 g\u002FL;\n   * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin;\n   * Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN);\n   * Totol bilirubin≤1.5×ULN;\n9. no absolute or relative contraindications to operation or biopsy;\n10. 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；\n11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;\n12. Be able to understand and sign the informed consent document;\n13. Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;\n3. Significant cardiovascular anomalies according to any of the following definition: 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.\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. Severe physical or mental diseases;\n6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);\n7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;\n8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;\n9. Having received immunotherapy and developed irAE level greater than Level 3;\n10. 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);\n11. Females in pregnancy or lactation;\n12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;\n13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.",{"count":140,"type":21},[95],"This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy (GC 101 TIL) in patients with advanced breast cancer. Autologous 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.",[206,100,228,161],"Advanced Breast Cancer",[101],{"date":185,"type":32},{"date":232,"type":32},"2021-11-19",{"date":234,"type":21},"2027-12-20",{"name":38,"class":39},{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":62},"100446804","early-phase-1-a-study-of-gc101-til-in-advanced-hepatobiliary-pancreatic-cancers-10hospital-100446804","NCT05098197","A Study of GC101 TIL in Advanced Hepatobiliary-Pancreatic Cancers (10hospital)","A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Hepatobiliary-Pancreatic Cancers","Inclusion Criteria:\n\n1. Age: 18 years to 75 years;\n2. Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized hepatobiliary cancer or pancreatic cancers;\n3. Expected life-span more than 3 months;\n4. Karnofsky≥60% or ECOG score 0-2;\n5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;\n7. At least 1 evaluable tumor lesion;\n8. Hematology and Chemistry（within 7 days prior to enrollment）:\n\n   * Absolute count of white blood cells≥2.5×10\\^9\u002FL;\n   * Absolute count of neutropils≥1.5×10\\^9\u002FL;\n   * Absolute count of lymphocytes ≥0.7×109\u002FL；\n   * Platelet count≥100×10\\^9；\n   * hemoglobin≥90 g\u002FL;\n   * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin;\n   * Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN);\n   * Totol bilirubin≤1.5×ULN;\n9. no absolute or relative contraindications to operation or biopsy;\n10. 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；\n11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;\n12. Be able to understand and sign the informed consent document;\n13. Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;\n3. Significant cardiovascular anomalies according to any of the following definition: 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.\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. Severe physical or mental diseases;\n6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);\n7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;\n8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;\n9. Having received immunotherapy and developed irAE level greater than Level 3;\n10. 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);\n11. Females in pregnancy or lactation;\n12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;\n13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.",{"count":140,"type":21},[95],"This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced hepatobiliary-pancreatic cancers. Autologous 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.",[247,248,100,161,249],"Advanced Liver Cancers","Tumor Infiltrating Lymphocyte","Advanced Pancreatic Cancers",{"date":185,"type":32},{"date":252,"type":32},"2021-09-26",{"date":254,"type":21},"2026-09-25",{"name":38,"class":39},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":270,"leadSponsor":271,"locationsCount":62},"100446803","early-phase-1-a-study-of-gc101-til-in-advanced-melanoma-10hospital-100446803","NCT05098184","A Study of GC101 TIL in Advanced Melanoma (10hospital)","A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Melanoma","Inclusion Criteria:\n\n1. Age: 18 years to 75 years;\n2. Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized melanoma;\n3. Expected life-span more than 3 months;\n4. Karnofsky≥60% or ECOG score 0-2;\n5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;\n7. At least 1 evaluable tumor lesion;\n8. Hematology and Chemistry（within 7 days prior to enrollment）:\n\n   * Absolute count of white blood cells≥2.5×10\\^9\u002FL;\n   * Absolute count of neutropils≥1.5×10\\^9\u002FL;\n   * Absolute count of lymphocytes ≥0.7×109\u002FL；\n   * Platelet count≥100×10\\^9；\n   * hemoglobin≥90 g\u002FL;\n   * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin;\n   * Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN);\n   * Totol bilirubin≤1.5×ULN;\n9. no absolute or relative contraindications to operation or biopsy;\n10. 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；\n11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;\n12. Be able to understand and sign the informed consent document;\n13. Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;\n3. Significant cardiovascular anomalies according to any of the following definition: 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.\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. Severe physical or mental diseases;\n6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);\n7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;\n8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;\n9. Having received immunotherapy and developed irAE level greater than Level 3;\n10. 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);\n11. Females in pregnancy or lactation;\n12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;\n13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.",{"count":140,"type":21},[95],"This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma. Autologous 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.",[267,248,100,161],"Advanced Melanoma",{"date":185,"type":32},{"date":252,"type":32},{"date":254,"type":21},{"name":38,"class":39},{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":279,"minAge":17,"maxAge":70,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":288,"leadSponsor":290,"locationsCount":62},"100446802","early-phase-1-a-study-of-gc201-til-in-advanced-gynecologic-tumors-10hospital-100446802","NCT05098171","A Study of GC201 TIL in Advanced Gynecologic Tumors (10hospital)","A Clinical Study on Signal Switch Receptor Modified Tumor Infiltrating Lymphocytes Injection (GC201 TIL) in Patients With Gynecologic Tumors","Inclusion Criteria:\n\n1. Age: 18 years to 75 years;\n2. Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized Gynecological tumors;\n3. Expected life-span more than 3 months;\n4. Karnofsky≥60% or ECOG score 0-2;\n5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;\n7. At least 1 evaluable tumor lesion;\n8. Hematology and Chemistry（within 7 days prior to enrollment）:\n\n   * Absolute count of white blood cells≥2.5×10\\^9\u002FL;\n   * Absolute count of neutropils≥1.5×10\\^9\u002FL;\n   * Absolute count of lymphocytes ≥0.7×109\u002FL；\n   * Platelet count≥100×10\\^9；\n   * hemoglobin≥90 g\u002FL;\n   * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin;\n   * Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN);\n   * Totol bilirubin≤1.5×ULN;\n9. no absolute or relative contraindications to operation or biopsy;\n10. 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；\n11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;\n12. Be able to understand and sign the informed consent document;\n13. Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;\n3. Significant cardiovascular anomalies according to any of the following definition: 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.\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. Severe physical or mental diseases;\n6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);\n7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;\n8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;\n9. Having received immunotherapy and developed irAE level greater than Level 3;\n10. 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);\n11. Females in pregnancy or lactation;\n12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;\n13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.","FEMALE",{"count":140,"type":21},[95],"This study is to investigate the safety and efficacy of signal switch receptor modified TIL (GC201 TIL) in patients with advanced gynecologic tumors. Autologous TILs from tumor resections or biopsies are first gene modified(TGF-β receptor or PD-1 gene modified TILs which could transfer the suppression signal surrounding the microenvironment of tumor bed into persistent T cell activation signal) and than expanded before i.v. infusion into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.",[284,285,100,161],"Advanced Gynecologic Tumors","Signal Switch Receptor Modified TIL",{"date":185,"type":32},{"date":252,"type":32},{"date":289,"type":21},"2027-09-25",{"name":38,"class":39},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":62},"100436789","early-phase-1-a-study-of-gc101-til-in-advanced-solid-tumors-tr-100436789","NCT04967833","A Study of GC101 TIL in Advanced Solid Tumors (TR)","A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age: 18 years to 75 years;\n2. Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized malignant tumors;\n3. Expected life-span more than 3 months;\n4. Karnofsky≥60% or ECOG score 0-2;\n5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;\n7. At least 1 evaluable tumor lesion;\n8. Hematology and Chemistry（within 7 days prior to enrollment）:\n\n   * Absolute count of white blood cells≥2.5×10\\^9\u002FL;\n   * Absolute count of neutropils≥1.5×10\\^9\u002FL;\n   * Absolute count of lymphocytes ≥0.7×109\u002FL；\n   * Platelet count≥100×10\\^9；\n   * hemoglobin≥90 g\u002FL;\n   * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin;\n   * Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN);\n   * Totol bilirubin≤1.5×ULN;\n9. No absolute or relative contraindications to operation or biopsy;\n10. 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；\n11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;\n12. Be able to understand and sign the informed consent document;\n13. Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;\n3. Significant cardiovascular anomalies according to any of the following definition: 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.\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. Severe physical or mental diseases;\n6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);\n7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;\n8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;\n9. Having received immunotherapy and developed irAE level greater than Level 3;\n10. 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);\n11. Females in pregnancy or lactation;\n12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;\n13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.",{"count":178,"type":21},[95],"This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with Advanced malignant solid tumors.Autologous 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.",[302],"Advanced Solid Tumors",[304],"TIL,Solid Tumors",{"date":185,"type":32},{"date":307,"type":32},"2021-04-22",{"date":309,"type":21},"2026-04-22",{"name":38,"class":39},{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":318,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":62},"100434954","early-phase-1-study-of-gc101-til-in-brain-glioma-soochow2-100434954","NCT04943913","Study of GC101 TIL in Brain Glioma (Soochow2)","A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Brain Glioma","Inclusion Criteria\n\n1. Age: 18 years to 75 years;\n2. Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized brain glioma;\n3. Expected life-span more than 3 months;\n4. Karnofsky≥60% or ECOG score 0-2;\n5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;\n7. At least 1 evaluable tumor lesion;\n8. Hematology and Chemistry（within 7 days prior to enrollment）:\n\n   * Absolute count of white blood cells≥2.5×10\\^9\u002FL;\n   * Absolute count of neutropils≥1.5×10\\^9\u002FL;\n   * Absolute count of lymphocytes ≥0.7×109\u002FL；\n   * Platelet count≥100×10\\^9；\n   * hemoglobin≥90 g\u002FL;\n   * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);\n   * Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin;\n   * Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN);\n   * Totol bilirubin≤1.5×ULN;\n9. No absolute or relative contraindications to operation or biopsy;\n10. 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；\n11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;\n12. Be able to understand and sign the informed consent document;\n13. Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;\n3. Significant cardiovascular anomalies according to any of the following definition: 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.\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. Severe physical or mental diseases;\n6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);\n7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;\n8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;\n9. Having received immunotherapy and developed irAE level greater than Level 3;\n10. 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);\n11. Females in pregnancy or lactation;\n12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;\n13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.",{"count":140,"type":21},[95],"This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant glioma . Autologous TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.",[322],"Glioma",{"date":185,"type":32},{"date":325,"type":32},"2021-05-06",{"date":327,"type":21},"2027-05-31",{"name":38,"class":39},""]