[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Weijia Fang, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":145},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,72,97,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100469706","phase-1-a-clinical-study-of-cea-targeted-car-t-in-the-treatment-of-cea-positive-advanced-malignant-solid-tumors-100469706",false,"NCT05396300","A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors","A Phase I Clinical Study of Anti-CEA CAR-T Therapy in the Treatment of CEA-positive Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female;\n2. Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer;\n3. After receiving at least second-line standard treatment and failing (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment methods;\n4. Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); If over 3 months, the patient's serum CEA should exceed 10ug\u002FL.\n5. At least one assessable lesion according to RECIST 1.1 criteria;\n6. ECOG score 0-2 points;\n7. No serious mental disorder;\n8. Unless otherwise specified, the function of the vital organs of the subject shall meet the following conditions:\n\n   1. Blood routine: white blood cells\\>2.0×109\u002FL, neutrophils\\>0.8×109\u002FL, lymphocytes cells\\>0.5×109\u002FL, platelets\\>50×109\u002FL, hemoglobin\\>90g\u002FL;\n   2. Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;\n   3. Renal function: serum creatinine≤2.0×ULN;\n   4. Liver function: ALT and AST ≤3.0×ULN (for those with liver tumor infiltration, it can be relaxed to≤5.0×ULN);\n   5. Total bilirubin≤2.0×ULN;\n   6. Oxygen saturation \\> 92% in non-oxygen state.\n9. Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;\n10. Subjects agree to use reliable and effective contraceptive methods for contraception within 1 year after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception);\n11. The patients themselves or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.\n\nExclusion Criteria:\n\n1. CNS metastases or meningeal metastases with clinical symptoms at the time of screening, or there is other evidence that the patient's central nervous system metastases or meningeal metastases have not been controlled, and are judged by the investigator to be unsuitable for inclusion;\n2. Participated in other clinical studies within 1 month before screening;\n3. vaccinated with live attenuated vaccine within 4 weeks before screening;\n4. Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);\n5. Active infection or uncontrollable infection requiring systemic treatment;\n6. Patients with intestinal obstruction, active gastrointestinal bleeding, or a history of gastrointestinal bleeding within 3 months;\n7. Except for alopecia or peripheral neuropathy, the toxicity of previous anti-tumor therapy has not improved to the baseline level or ≤ grade 1;\n8. Suffering from any of the following heart diseases:\n\n   1. New York Heart Association (NYHA) stage III or IV congestive heart failure;\n   2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;\n   3. Clinically significant ventricular arrhythmia, or history of syncope of unknown origin (caused by vasovagal except those caused by neurosis or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n9. Patients with active autoimmune disease, or other patients requiring long-term immunosuppressive therapy;\n10. Suffering from other uncured malignant tumors in the past 3 years or at the same time, except cervical carcinoma in situ and basal cell carcinoma of the skin;\n11. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;\n12. Women who are pregnant or breastfeeding;\n13. Other investigators deem it unsuitable to participate in the study.","ALL","18 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.",[26,27,28],"Colorectal Cancer","Solid Cancers","Gastric Cancer",[30,31,32],"CAR-T","CEA","CEA-positive advanced malignant solid tumors","RECRUITING","2026-04-22",{"date":36,"type":37},"2026-04-28","ACTUAL",{"date":39,"type":37},"2022-05-25",{"date":41,"type":20},"2027-12-30",{"name":43,"class":44},"Weijia Fang, MD","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":50,"conditions":57,"keywords":61,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100625236","early-phase-1-an-open-label-single-arm-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetic-profile-and-preliminary-efficacy-of-kt032-cell-injection-in-patients-with-mesothelin-positive-advanced-solid-tumors-100625236","NCT07420010","An Open-label, Single-arm Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of KT032 Cell Injection in Patients With Mesothelin-positive Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Aged 18 to 75 years (inclusive), any gender;\n2. Histopathologically confirmed diagnosis of advanced solid tumors (including but not limited to ovarian cancer, mesothelioma, colon cancer, etc.), with peritoneal or intraperitoneal metastasis as the primary disease manifestation;\n3. Progression or intolerance to prior systemic standard-of-care treatment according to guidelines (systemic therapy includes but is not limited to systemic chemotherapy, molecular targeted therapy, etc.), and unsuitable for surgery or local treatment (including ablation therapy, interventional therapy, and radiotherapy); specifically: Ovarian cancer: Recurrence during or within 6 months after second-line or later platinum-based chemotherapy; Mesothelioma: Failure of, intolerance to, or ineligibility for at least first-line therapy; Colon cancer: Failure of, intolerance to, or ineligibility for at least third-line therapy;\n\n   1. Ovarian cancer: Progression, intolerance, or ineligibility after second-line standard therapy including carboplatin ± paclitaxel\u002Falbumin-bound paclitaxel\u002Fdocetaxel\u002Fpegylated liposomal doxorubicin;\n   2. Advanced colon cancer: Progression, intolerance, or ineligibility after third-line standard therapy including cetuximab ± irinotecan\u002Fregorafenib\u002Ffruquintinib\u002Ftrifluridine\u002Ftipiracil;\n   3. Mesothelioma: Progression, intolerance, or ineligibility after first-line standard therapy with pemetrexed combined with cisplatin\u002Fcarboplatin;\n4. Presence of at least one measurable lesion per RECIST 1.1 criteria;\n5. MSLN expression positivity in tumor tissue detected by immunohistochemistry (IHC), defined as IHC ≥2+ (i.e., ≥26% positive tumor cells stained); subjects must undergo fresh tumor tissue biopsy; if biopsy is not feasible, at least 5 archived tumor tissue slides collected within one year must be provided (if multiple tumor tissue collections exist, the most recent sample is preferred);\n6. ECOG performance status 0-1 (see Appendix 1) and estimated life expectancy \\>12 weeks;\n7. Adequate organ function with all following laboratory results prior to enrollment:\n\n   Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL (growth factor support allowed, but must not have received within 7 days prior to laboratory testing); Absolute lymphocyte count (ALC) ≥0.7×10⁹\u002FL; Platelets ≥100×10⁹\u002FL (no transfusion support within 7 days prior to laboratory testing); Hemoglobin ≥90 g\u002FL (no RBC transfusion within 7 days prior to laboratory testing; recombinant human erythropoietin allowed); Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN); Total serum bilirubin ≤2×ULN; ALT and AST may be extended to ≤5×ULN if abnormalities are determined by the investigator to be due to disease (e.g., hepatic metastases or biliary obstruction) or Gilbert's syndrome; Renal function: Creatinine clearance (CrCl) ≥50 mL\u002Fmin calculated by Cockcroft-Gault formula; Coagulation function: Fibrinogen ≥1.0 g\u002FL; Activated partial thromboplastin time ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN; Oxygen saturation \\>91% (on room air); Left ventricular ejection fraction (LVEF) ≥50%;\n8. Recovery from all toxicities related to prior treatment to acceptable baseline status, or recovery to normal or Grade 1 per NCI CTCAE 5.0, as determined by the investigator; except for toxicities not expected to increase safety risk of subsequent investigational product infusion, such as alopecia, vitiligo, etc.;\n9. Agreement by subjects and their partners to use effective contraceptive methods (excluding rhythm method) from the time of informed consent signature until one year after CAR-T cell infusion;\n10. Written informed consent on IRB\u002FIEC-approved consent form obtained personally from the subject prior to initiation of any screening procedures.\n\nExclusion Criteria:\n\n1. Other malignancies within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, or ductal carcinoma in situ of the breast after radical surgery;\n2. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA titer above the lower limit of detection of the quantitative assay at the study site; Hepatitis C virus (HCV) antibody positive with peripheral blood HCV RNA above the lower limit of detection of the quantitative assay at the study site; Human immunodeficiency virus (HIV) antibody positive; Positive syphilis test;\n3. Patients with central nervous system metastases and\u002For other unstable central nervous system diseases (hemorrhage, active infarction, infection, etc.);\n4. Receipt of live attenuated vaccine within 4 weeks prior to cell injection;\n5. History of hypersensitivity to prior immunotherapy, allergy or intolerance to fludarabine, cyclophosphamide, albumin-bound paclitaxel conditioning regimen drugs, or tocilizumab, or allergy to components of the investigational product formulation, or history of other severe allergic reactions;\n6. Poorly controlled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg) or clinically significant (e.g., active) cardiovascular disease, such as cerebrovascular accident (within 6 months prior to main informed consent signature), myocardial infarction (within 6 months prior to main informed consent signature), unstable angina, New York Heart Association (NYHA) Class II or greater congestive heart failure, or serious arrhythmia not controlled by medication or potentially affecting study treatment; Clinically significant abnormalities on ECG in 3 consecutive readings (at least 5 minutes apart each) or mean QTcB ≥450 ms;\n7. Other severe organic diseases or psychiatric disorders;\n8. Chronic obstructive pulmonary disease, interstitial lung disease, or clinically significant abnormal pulmonary function test results;\n9. Autoimmune diseases: History of autoimmune disease deemed unsuitable for this study by the investigator, such as systemic lupus erythematosus, vasculitis, infiltrative lung disease (subjects with vitiligo are excluded from this exclusion criterion);\n10. Systemic corticosteroids (topical use allowed), hydroxyurea, immunomodulatory agents (e.g., α or γ interferon, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.) within 2 weeks prior to screening or planned use during the study (if long-term use exists);\n11. Chemotherapy within 2 weeks prior to cell injection, immunotherapy within 4 weeks, radiotherapy within 12 weeks prior to infusion, or other antineoplastic agents with insufficient washout period of less than 5 half-lives;\n12. Pregnant or lactating women, and female subjects planning pregnancy within 1 year after cell infusion;\n13. Subjects with any concurrent medical condition or disease that the investigator determines may interfere with study conduct;\n14. Receipt of other cellular or gene therapy products within 3 months prior to cell injection, or patients deemed unsuitable for enrollment by the investigator;\n15. Patients whom the investigator determines will have difficulty completing all study visits or procedures (including follow-up period), or with insufficient compliance; or patients deemed unsuitable for enrollment by the investigator.","75 Years",{"count":54,"type":20},24,[56],"EARLY_PHASE1",[58,59,60],"Ovarian Cancer","Mesothelioma","Colon Cancer",[30,62],"Mesothelin-positive Advanced Solid Tumors","NOT_YET_RECRUITING","2026-02-12",{"date":66,"type":37},"2026-02-19",{"date":68,"type":20},"2026-03-15",{"date":70,"type":20},"2028-12-31",{"name":43,"class":44},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100579188","phase-1-study-of-cea-targeting-car-t-ptc13-in-the-treatment-of-cea-positive-advanced-malignant-solid-tumors-100579188","NCT06821048","Study of CEA Targeting CAR-T (PTC13) in the Treatment of CEA-Positive Advanced Malignant Solid Tumors","A Phase I Clinical Study of Anti-CEA CAR-T (PTC13) Therapy in the Treatment of CEA-positive Advanced Malignant Solid Tumors","Inclusion Criteria:\n\nSubjects must meet all the following criteria to be eligible for the study:\n\n1. Age≥18 years, regardless of gender.\n2. Diagnosed with advanced, metastatic, or recurrent malignant tumors confirmed by histology or pathology, primarily including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, lung cancer, or cholangiocarcinoma.\n3. Failure of at least second-line standard therapy (due to disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or a lack of effective treatment options.\n4. Immunohistochemical staining of tumor samples within 3 months confirming CEA positivity (distinct membrane staining with a positivity rate of≥10%); if the immunohistochemical result of the tumor sample is more than 3 months old at the time of screening (distinct membrane staining with a positivity rate of≥10%), the patient's serum CEA must exceed 10µg\u002FL.\n5. At least one evaluable lesion according to RECIST 1.1 criteria.\n6. ECOG score of 0-2 (Appendix 2).\n7. No severe psychiatric disorders.\n8. Unless specifically stated otherwise, subjects' major organ functions must meet the following conditions:\n\n   1. Blood routine: WBC\\>2.0×109\u002FL, neutrophils\\>0.8×109\u002FL, lymphocytes\\>0.5×109\u002FL, platelets\\>50×109\u002FL, hemoglobin\\>90g\u002FL;\n   2. Cardiac function: Echocardiography indicating a left ventricular ejection fraction≥50%, and no significant abnormalities on electrocardiogram;\n   3. Renal function: Serum creatinine≤2.0×ULN;\n   4. Liver function: ALT and AST ≤3.0×ULN (may be relaxed to≤5.0×ULN if liver tumor infiltration is present);\n   5. Total bilirubin≤2.0×ULN;\n   6. Oxygen saturation\\>92% without supplemental oxygen. 9. Eligible for apheresis or venous blood collection, with no contraindications for cell collection.\n\n      10\\. Subjects agree to use reliable and effective contraceptive methods from signing the informed consent form until 1 year after receiving CAR-T cell infusion (excluding natural family planning methods).\n\n      11\\. The patient or their guardian agree to participate in this clinical trial and signs the ICF, indicating an understanding of the trial's purpose and procedures and willingness to participate.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will be excluded from the study:\n\n1. Clinically symptomatic central nervous system or leptomeningeal metastasis at the time of screening, or other evidence suggesting that central nervous system or leptomeningeal metastases are not controlled, as judged unsuitable for inclusion by the investigator.\n2. Participation in another clinical study within 1 month prior to screening.\n3. Receipt of live attenuated vaccines within 4 weeks prior to screening.\n4. Receipt of the following anti-tumor treatments before screening: Chemotherapy, targeted therapy, or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter).\n5. Presence of active or uncontrolled infections requiring systemic treatment.\n6. Patients with intestinal obstruction, active gastrointestinal bleeding, a history of major gastrointestinal bleeding within 3 months, severe gastroduodenal ulcers, or severe gastrointestinal inflammation such as ulcerative colitis.\n7. Toxicity from previous anti-tumor therapy that has not improved to baseline levels or≤Grade 1, except for alopecia or peripheral neuropathy.\n8. Presence of any of the following cardiac conditions:\n\n   1. New York Heart Association (NYHA) Stage III or IV congestive heart failure;\n   2. Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to enrollment;\n   3. Clinically significant ventricular arrhythmia or history of unexplained syncope (excluding vasovagal or dehydration-related causes);\n   4. History of severe non-ischemic cardiomyopathy.\n9. Presence of active autoimmune diseases or other conditions requiring long-term immunosuppressive therapy.\n10. Diagnosis of another untreated malignancy within the past 3 years, except for in situ cervical cancer or basal cell carcinoma of the skin.\n11. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA levels exceeding the normal range; positive for hepatitis C virus (HCV) antibodies with peripheral blood HCV RNA levels exceeding the normal range; positive for human immunodeficiency virus (HIV) antibodies; or positive syphilis test.\n12. Pregnant or breastfeeding women.\n13. Any other conditions deemed unsuitable for participation in the study by the investigator.",{"count":80,"type":20},18,[23],"This is a phase I clinical study to evaluate the safety and tolerability of FAST targeted chimeric antigen receptor (CAR)-T cells (PTC13) in patients with carcinoembryonic antigen (CEA)-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of FAST CAR-T (PTC13) and phase II Recommended dose.",[26,84,85,86],"Stomach Cancer","Pancreatic Cancer","Metastatic Cancer",[88,32],"FAST CAR-T","2026-01-21",{"date":91,"type":37},"2026-01-23",{"date":93,"type":37},"2024-07-24",{"date":95,"type":20},"2027-12-01",{"name":43,"class":44},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":45},"100479074","phase-1-a-clinical-study-of-cd70-targeted-car-t-in-the-treatment-of-cd70-positive-advancedmetastatic-solid-tumors-100479074","NCT05518253","A Clinical Study of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced\u002FMetastatic Solid Tumors","A Phase I Clinical Study of CD70-targeting CAR-T Therapy in the Treatment of CD70-positive Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female;\n2. Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) diagnosed as advanced\u002Fmetastatic solid tumor (positive tumor CD70 expression (tumor CD70 positive (IHC 3+) confirmed by histology or pathology));\n3. Failure or intolerance after standard treatment (disease progression or intolerance such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.), and there is currently no effective treatment;\n4. According to the RECIST version 1.1 standard, at least one target lesion with measurable diameter and evaluable, measurable lesions are defined as: extranodal CT scan long diameter ≥ 10mm, lymph node lesions CT scan short diameter ≥ 15mm, scan slice thickness Not larger than 5mm, and has not received local treatment;\n5. ECOG 0-2 points;\n6. The expected survival time is more than 12 weeks;\n7. No serious mental disorder;\n8. The function of important organs is basically normal:\n\n   1. Hematopoietic function: neutrophils\\>1.0×109\u002FL, platelets\\>75×109\u002FL, hemoglobin\\>80g\u002FL;\n   2. Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;\n   3. Renal function: serum creatinine≤2.0×ULN;\n   4. Liver function: ALT and AST ≤2.0×ULN (for patients with liver tumor infiltration, it can be relaxed to ≤3.0×ULN);\n   5. Total bilirubin ≤2.0×ULN (Gilbert syndrome or combined liver tumor infiltration can be relaxed to ≤3.0×ULN);\n   6. Oxygen saturation \\> 92% in non-oxygen state.\n9. Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;\n10. Subjects agree to use reliable and effective contraceptive methods for contraception (excluding safe period contraception) within 1 year after signing the informed consent form to receiving CAR-T cell infusion;\n11. Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.\n\nExclusion Criteria:\n\n1. Received anti-CD70 drug treatment before screening;\n2. Active\u002Fsymptomatic central nervous system metastases or meningeal metastases at the time of screening; subjects with brain metastases who have been treated must be confirmed to have no imaging-proven progression ≥4 weeks after the end of treatment before they can be enrolled;\n3. Received any of the following treatments prior to screening:\n\n   1. Participated in other interventional clinical studies before screening, including: the last use of unmarketed new drugs is less than 3 months before cell reinfusion, or the last use of marketed drugs is less than 5 half-lives from cell reinfusion;\n   2. Received anti-tumor therapy such as chemotherapy and targeted therapy within 2 weeks or at least 5 half-lives (whichever is shorter) before apheresis;\n   3. Received systemic corticosteroid therapy at doses greater than 10 mg\u002Fday prednisone (or equivalent doses of other corticosteroids) within 2 weeks prior to apheresis (inhalation or topical is allowed in the absence of active autoimmune disease Use steroids and adrenal corticosteroid replacement at doses greater than 10 mg\u002Fday of prednisone);\n   4. Received live attenuated vaccine within 4 weeks before screening;\n4. Active infection or uncontrollable infection requiring systemic treatment within 1 week before screening;\n5. Malignant tumors other than the target tumor within 3 years prior to screening, except for the following: malignant tumors that have received radical treatment and no known active disease within ≥ 3 years prior to enrollment; or adequately treated of non-melanoma skin cancers with no evidence of disease;\n6. Have any of the following heart conditions:\n\n   1. New York Heart Association (NYHA) stage III or IV congestive heart failure;\n   2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;\n   3. Clinically significant ventricular arrhythmia, or a history of unexplained syncope (except those caused by vasovagal or dehydration);\n   4. History of severe nonischemic cardiomyopathy.\n7. Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.;\n8. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA titer test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive; cytomegalovirus (CMV) DNA test positive;\n9. The subject has experienced venous thromboembolic events (eg: pulmonary embolism) and still needs anticoagulation therapy, or meets the following conditions: a. Bleeding with grades 3 to 4 for more than 30 days; b. venous thrombosis Sequelae (such as persistent dyspnea and hypoxia); (Note: although subjects with venous thrombosis but not meeting the above conditions can participate in the trial);\n10. Poorly controlled hypertension, defined as systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg (blood pressure values measured based on the average of 3 readings at least 2 minutes apart, blood pressure ≥ 150\u002F90 mmHg at initial screening is acceptable Antihypertensive treatment, screening can be performed if the blood pressure is less than 150\u002F90mmHg and well controlled after treatment);\n11. Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving CAR-T cell reinfusion;\n12. Other investigators deem it inappropriate to participate in the study.",{"count":105,"type":20},30,[23],"This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CD70-positive advanced\u002Fmetastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.",[109,110,111,58,112],"Metastatic Tumor","Advanced Solid Tumor","Renal Cell Carcinoma","Cervix Cancer",[30,114,115],"CD70","CD70-positive advanced\u002Fmetastatic solid tumors","2025-05-26",{"date":118,"type":37},"2025-05-31",{"date":120,"type":37},"2022-05-30",{"date":122,"type":20},"2027-05-30",{"name":43,"class":44},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":45},"100505498","phase-2-neoadjuvant-treatment-of-tislelizumab-combined-chemotherapy-for-locally-advanced-oral-squamous-cell-carcinoma-a-single-arm-prospective-phase-ii-trial-100505498","NCT05862168","Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma ：A Single-arm, Prospective, Phase II Trial","Neoadjuvant Tislelizumab Combined With Albumin-paclitaxel, Cisplatin, and Fluorouracil in Patients With Locally Advanced Oral Squamous Cell Carcinoma ：A Single-arm, Prospective，Phase II Study","Inclusion Criteria:\n\n1. Signed the informed consent form\n2. Histopathological diagnosis of oral squamous cell carcinoma\n3. Age: 18-75 years old , Gender: male and female\n4. Primary tumor with a clinical stage of III\u002FIVb (T1-2N+M0或T3-4N0-3M0, AJCC2018)\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1\n6. No previous systematic therapy for OSCC (including chemotherapy, EGFR inhibitors, VEGFR inhibitors such as bevacizumab, immune checkpoint inhibition such as anti-PD-1 or PD-L1 antibodies, anti-ctLA-4 antibodies, etc.);\n7. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)\n8. Adequte organ function based on laboratory test values obtained during the screening period：1）Blood routine: white blood cells (WBCs) \\>3.0× 109\u002FL, ANC \\>1.5× 109\u002FL, platelets \\>75× 109\u002FL, hemoglobin \\>9 g\u002FL, 2）Liver function: alanine amino transferase\u002Faspartate amino transferase (ALAT\u002FASAT) \\\u003C2.5 times the upper limit of normal and bilirubin \\\u003C1.5 times the upper limit of normal，3）Renal function: Serum creatinine \\\u003C1.5 times the upper limit of normal，4）Coagulation function: INR, PT, APTT\\\u003C1.5 times the upper limit of normal，5）Left ventricular ejection fraction (LVEF) ≥ 50%\n9. contraception\n\nExclusion Criteria:\n\n1. Known history of malignancy, unless been cured and no recurrence for 5 years\n2. Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy\n3. Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck\n4. Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, or autoimmune disease that may recur or plan treatment as judged by the investigator.\n5. Active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or ulcerative colitis) disease.\n6. Subjects with known active pulmonary tuberculosis (TB) and suspected active TB require clinical examination to rule out; known active syphilis infection.\n7. Serious infections within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or serious pneumonia; active infections (excluding antiviral therapy for hepatitis B or C) that have received systemic anti-infective therapy within 2 weeks prior to the first dose.\n8. Known human immunodeficiency virus (HIV) infection\n9. Subjects with untreated active hepatitis B (HBsAg positive and HBV-DNA more than 1000 copies\u002Fml \\[200 IU\u002Fml\\] or above the lower limit of detection) and anti-hepatitis B virus treatment during study treatment are required for subjects with hepatitis B; subjects with active hepatitis C (HCV antibody positive and HCV-RNA level above the lower limit of detection).\n10. History of pneumonitis\u002Finterstitial lung disease requiring systemic corticosteroids or current pneumonitis.\n11. Known allergic reaction to any ingredients or excipients of the therapy\n12. Participation in other clinical trials within 30 days before enrollment\n13. Pregnant or lactating women\n14. Known alle Other situations that the investigator considers unsuitable with respect to participating in the trial",{"count":105,"type":20},[133],"PHASE2","TPF is still recommended as the preferred induction chemotherapy regimen for nonsurgical treatment of patients with LA HNSCC. Based on the KEYNOTE-048 study, all major guidelines recommend PD-1 monotherapy or PD-1 combined with chemotherapy as the new first-line standard treatment for patients with advanced HNSCC. The immunotherapy in operable LA HNSCC was also explored as neoadjuvant therapy due to the excellent data in advanced HNSCC. These explorations have also achieved good results. Therefore, this study aims to explore the pathological remission rate, the long-term benefit and safety of Tislelizumab combined with albumin paclitaxel, cisplatin and fluorouracil for locally advanced oral squamous cell carcinoma.",[136],"Oral Squamous Cell Carcinoma","2023-07-14",{"date":139,"type":37},"2023-07-17",{"date":141,"type":37},"2023-05-08",{"date":143,"type":20},"2028-06-30",{"name":43,"class":44},""]