[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen University General Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":257},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,66,87,106,126,161,183,205,223,241],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100640520","phase-1-efficacy-and-safety-of-cd19-carp40-t-in-patients-with-relapsedrefractory-cd19-positive-hematologic-malignancies-100640520",false,"NCT07584889","Efficacy and Safety of CD19-CAR.p40-T in Patients With Relapsed\u002FRefractory CD19-Positive Hematologic Malignancies","Efficacy and Safety of Autocrine p40-Expressing CD19-Targeted Chimeric Antigen Receptor T Cells (CD19-CAR.p40-T) in Patients With Relapsed\u002FRefractory CD19-Positive Hematologic Malignancies","CAR-p40-T","Inclusion Criteria\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1. • Aged 18 to 75 years, male or female;\n2. • Histologically or cytologically diagnosed with relapsed\u002Frefractory CD19-positive hematologic malignancy according to the 2022 World Health Organization (WHO) diagnostic criteria;\n3. • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n4. • Life expectancy of at least 3 months;\n5. • No contraindications to peripheral blood leukapheresis;\n6. • CD19 expression on tumor cells confirmed by flow cytometry and\u002For immunohistochemistry;\n7. • No severe cardiac, pulmonary, hepatic, or renal dysfunction;\n8. • Able to understand and willing to provide written informed consent. Exclusion Criteria\n\nSubjects who meet any of the following criteria should be excluded from enrollment:\n\n1. History of allergy to any component of the cellular product;\n2. Complete blood count meeting any of the following criteria: white blood cell count (WBC) ≤1 × 10⁹\u002FL, absolute neutrophil count (ANC) ≤0.5 × 10⁹\u002FL, absolute lymphocyte count (ALC) ≤0.5 × 10⁹\u002FL, or platelet count (PLT) ≤25 × 10⁹\u002FL;\n3. Laboratory abnormalities including, but not limited to, serum total bilirubin ≥1.5 mg\u002FdL; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.5 times the upper limit of normal; or serum creatinine ≥2.0 mg\u002FdL;\n4. Class III or IV cardiac insufficiency according to the New York Heart Association (NYHA) functional classification, or left ventricular ejection fraction (LVEF) \\\u003C50% by echocardiography;\n5. Abnormal pulmonary function, with oxygen saturation \\\u003C92% on room air;\n6. History of myocardial infarction, cardiac angioplasty or stent placement, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;\n7. Grade 3 hypertension with poor blood pressure control despite medication;\n8. History of traumatic brain injury, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease;\n9. Autoimmune disease, immunodeficiency, or other conditions requiring treatment with immunosuppressive agents;\n10. Uncontrolled active infection;\n11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;\n12. Receipt of a live vaccine within 4 weeks prior to enrollment;\n13. Positive test results for HIV, HBV, HCV, or TPPA\u002FRPR, or HBV carrier status;\n14. History of alcohol abuse, drug abuse, or psychiatric illness;\n15. Participation in any other clinical study within 3 months prior to enrollment in this clinical study;\n16. Female subjects who meet any of the following conditions:\n\n    1. Pregnant or breastfeeding;\n    2. Planning to become pregnant during the study; or\n    3. Of childbearing potential and unwilling or unable to use effective contraception;\n17. Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":21,"type":22},10,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","1. Study Title:\n\n   A Study on the Efficacy and safety of Autocrine p40-Expressing CD19-Targeted Chimeric Antigen Receptor T Cells (CD19-CAR.p40-T) in Patients With Relapsed\u002FRefractory CD19-Positive Hematologic Malignancies\n2. Study Objectives:\n\n   2.1.1 Primary Objective To evaluate the safety of autocrine p40-expressing CD19-targeted chimeric antigen receptor T cells (CD19-CAR.p40-T) in the treatment of patients with relapsed\u002Frefractory CD19-positive hematologic malignancies.\n\n   2.1.2 Secondary Objective To evaluate the efficacy of autocrine p40-expressing CD19-targeted chimeric antigen receptor T cells (CD19-CAR.p40-T) in the treatment of patients with relapsed\u002Frefractory CD19-positive hematologic malignancies.\n\n   2.1.3 Exploratory Objective To evaluate the in vivo expansion and persistence of CD19-CAR.p40-T cells.\n3. Participant Intervention:\n\nParticipants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19-CAR.p40-T cell infusion. The CD19-CAR.p40-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.",[29,30,31],"B Cell Lymphoma","Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","RECRUITING","2026-05-07",{"date":35,"type":36},"2026-05-13","ACTUAL",{"date":38,"type":36},"2024-04-20",{"date":40,"type":22},"2029-04-19",{"name":42,"class":43},"Shenzhen University General Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":44},"100636245","phase-2-bugitinib-combined-with-venetoclax-and-cytarabine-in-relapsedrefractory-acute-myeloid-leukemia-100636245","NCT07563179","Bugitinib Combined With Venetoclax and Cytarabine in Relapsed\u002FRefractory Acute Myeloid Leukemia","A Prospective, Single-Arm Study of Bugitinib Combined With Venetoclax and Cytarabine in Relapsed\u002FRefractory Acute Myeloid Leukemia (Non-M3)","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n* Age 18-70 years (inclusive), regardless of sex;\n* Diagnosis of non-M3 acute myeloid leukemia (AML), and meeting at least one of the following conditions:\n\n  * Failure to achieve complete remission (CR) after standard induction chemotherapy;\n  * First CR duration ≤12 months;\n  * First CR duration \\>12 months, followed by relapse and failure of at least one line of standard chemotherapy;\n  * Relapsed disease after ≥2 prior lines of therapy;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n* Estimated life expectancy ≥3 months;\n* Adequate organ function, defined as:\n\n  * Cardiac: left ventricular ejection fraction (LVEF) ≥50% by echocardiography, with no clinically significant ECG abnormalities;\n  * Renal: serum creatinine ≤2.0 × upper limit of normal (ULN) and creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault);\n  * Hepatic: ALT and AST ≤3.0 × ULN;\n  * Total bilirubin ≤2.0 × ULN (≤3.0 × ULN for patients with Gilbert syndrome);\n  * Oxygen saturation ≥92% on room air;\n* Ability to take oral medications and comply with study procedures;\n* Willingness to participate and provide written informed consent.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n* Known hypersensitivity to any study drug or its excipients;\n* Active central nervous system (CNS) leukemia (patients with prior CNS involvement who achieved complete remission and are clinically stable may be eligible);\n* Active, uncontrolled bacterial, viral, or systemic fungal infection;\n* Known hereditary bleeding or coagulation disorders, history of non-traumatic bleeding or thromboembolism, or other conditions that may increase bleeding risk;\n* Evidence of active infection, including:\n\n  * Hepatitis B virus (HBV) infection with positive HBsAg or HBcAb and HBV DNA \\>100 copies\u002FmL;\n  * Hepatitis C virus (HCV) antibody positive with detectable HCV RNA;\n  * Human immunodeficiency virus (HIV) infection;\n  * Positive test for syphilis;\n* Active bleeding or clinically significant bleeding tendency, including but not limited to:\n\n  * Active gastrointestinal bleeding, intracranial hemorrhage, or bleeding in other vital organs;\n  * Grade ≥3 bleeding event within 4 weeks prior to enrollment (per CTCAE);\n  * Known hereditary bleeding disorders (e.g., hemophilia);\n  * Severe platelet dysfunction not correctable;\n* Significant cardiovascular disease, including but not limited to:\n\n  * New York Heart Association (NYHA) class III-IV heart failure;\n  * Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment;\n  * Clinically significant ventricular arrhythmias or unexplained syncope (excluding vasovagal or dehydration-related causes);\n  * Severe cardiomyopathy;\n* History of or concurrent other malignancies (except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);\n* Clinically significant central nervous system disorders (e.g., epilepsy, stroke, psychiatric disorders) that may affect compliance or safety;\n* Participation in another interventional clinical trial within 30 days prior to enrollment;\n* Pregnant or breastfeeding women, or subjects planning pregnancy during the study period or within 6 months after the last dose and unwilling to use effective contraception;\n* Known or suspected drug abuse or alcohol dependence;\n* Requirement for concomitant use of strong CYP3A inhibitors or inducers that cannot be discontinued or dose-adjusted per protocol;\n* Any other condition that, in the investigator's opinion, would make the subject unsuitable for participation.","70 Years",{"count":21,"type":22},[26],"This is a prospective, single-arm, exploratory study evaluating the combination of Bugitinib, Venetoclax, and Cytarabine in adult patients with relapsed or refractory acute myeloid leukemia (AML), excluding M3 subtype. The primary objective is to assess the rate of MRD (Minimal Residual Disease) negativity and the duration of MRD-negative status following treatment. Secondary objectives include evaluating overall response rate (CR\u002FCRi), overall survival, progression-free survival, and safety. Treatment consists of induction therapy with Bugitinib and Venetoclax orally for 28 days combined with Cytarabine intravenously for 7-10 days per cycle. Patients who do not achieve complete remission after the first cycle may receive a second cycle with dose-adjusted Cytarabine. MRD and bone marrow assessments will guide therapy continuation, consolidation, or maintenance. Safety and tolerability will be closely monitored throughout the study.",[31,57],"Relapse\u002FRecurrence","2026-04-28",{"date":60,"type":36},"2026-05-01",{"date":62,"type":36},"2026-04-21",{"date":64,"type":22},"2029-06-30",{"name":42,"class":43},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":44},"100632047","phase-1-efficacy-and-safety-of-cd19cd20-cartruc-t-in-relapsedrefractory-b-cell-lymphoma-100632047","NCT07508605","Efficacy and Safety of CD19\u002FCD20 CAR\u002FTRuC-T in Relapsed\u002FRefractory B-Cell Lymphoma","CAR\u002FTRuC-T","Inclusion Criteria\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1. Aged 18 to 75 years, regardless of sex;\n2. Histologically confirmed relapsed\u002Frefractory B-cell lymphoma according to the 2020 World Health Organization (WHO) classification;\n3. ECOG performance status of 0-2;\n4. Expected survival of at least 3 months;\n5. CD20 expression on tumor cells confirmed by flow cytometry and\u002For immunohistochemistry;\n6. Patients who are resistant\u002Frefractory to CD19 CAR-T cell therapy or have low CD19 expression;\n7. No severe cardiac, pulmonary, hepatic, or renal disease;\n8. Able to understand and willing to sign the informed consent form for this study;\n9. No contraindications to peripheral blood mononuclear cell collection\u002Fapheresis;\n10. At least one measurable and evaluable lesion according to RECIST 1.1;\n11. Must have previously received standard first-line and second-line therapy;\n12. No antibody-based therapy within 2 weeks prior to cell therapy. Exclusion Criteria\n\nSubjects meeting any of the following criteria will be excluded:\n\n1. History of allergy to any component of the cell product;\n2. Abnormal complete blood count meeting any of the following: WBC ≤1 × 10⁹\u002FL, ANC ≤0.5 × 10⁹\u002FL, ALC ≤0.5 × 10⁹\u002FL, or PLT ≤25 × 10⁹\u002FL;\n3. Laboratory abnormalities including, but not limited to, any of the following: total serum bilirubin ≥1.5 mg\u002FdL; ALT or AST \\>2.5 times the upper limit of normal; serum creatinine ≥2.0 mg\u002FdL;\n4. New York Heart Association (NYHA) Class III or IV heart failure, or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography;\n5. Abnormal pulmonary function, with oxygen saturation \\\u003C92% on room air;\n6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;\n7. Grade 3 hypertension with poor blood pressure control despite medication;\n8. History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease;\n9. Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy;\n10. Presence of uncontrolled active infection;\n11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;\n12. Receipt of a live vaccine within 4 weeks prior to enrollment;\n13. Positive for HIV, HBV, HCV, or TPPA\u002FRPR, or HBV carrier status;\n14. History of alcohol abuse, drug abuse, or psychiatric illness;\n15. Participation in any other clinical study within 3 months prior to enrollment in this study;\n16. Female subjects meeting any of the following conditions:\n\n    1. currently pregnant or breastfeeding;\n    2. planning to become pregnant during the study period; or\n    3. of childbearing potential and unwilling or unable to use effective contraception;\n17. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.",{"count":74,"type":22},20,[25,26],"1. Study Title:\n\n   A Study on the Efficacy and safety of CD19\u002FCD20 CAR\u002FTRuC-T in Relapsed\u002FRefractory B-Cell Lymphoma\n2. Study Objectives:\n\n   Primary Objective: To evaluate the safety of CD19\u002FCD20 CAR\u002FTRuC-T cell therapy in patients with relapsed\u002Frefractory B-cell lymphoma.\n\n   Secondary Objective: To evaluate the efficacy of CD19\u002FCD20 CAR\u002FTRuC-T cell therapy in patients with relapsed\u002Frefractory B-cell lymphoma.\n\n   Exploratory Objective: To assess in vivo expansion and persistence of infused CD19\u002FCD20 CAR\u002FTRuC-T cells.\n3. Participant Intervention:\n\nParticipants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19\u002FCD20 CAR\u002FTRuC-T cell infusion. The CAR\u002FTRuC-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.",[78],"Relapsed\u002FRefractory B-cell Lymphoma","2026-03-27",{"date":81,"type":36},"2026-04-02",{"date":83,"type":36},"2025-01-01",{"date":85,"type":22},"2027-12-30",{"name":42,"class":43},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":44},"100623679","phase-1-efficacy-and-safety-of-msln-car-t-in-advanced-malignant-tumors-100623679","NCT07399769","Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Aged 18-75 years (≥18 and ≤75 years), either sex;\n2. The subject voluntarily participates in the study and provides written informed consent signed by the subject or his\u002Fher legally authorized representative;\n3. Histopathologically confirmed unresectable, locally advanced, recurrent, or metastatic solid malignant tumor; according to the AJCC TNM staging system (8th edition, 2017), subjects diagnosed with stage III or stage IV solid malignant tumors;\n4. Presence of measurable and evaluable lesions according to RECIST v1.1;\n5. Positive MSLN expression in tumor tissue confirmed by immunohistochemistry (IHC);\n6. The subject must have received standard first-line therapy and has experienced disease progression or is intolerant to such therapy;\n7. The subject is not suitable for curative treatment modalities such as definitive chemoradiotherapy and\u002For surgery\u002Fimmune checkpoint inhibitors, or refuses surgical resection;\n8. No antibody-based therapy administered within 2 weeks prior to cell therapy;\n9. ECOG performance status 0-2;\n10. No contraindications to peripheral blood leukapheresis;\n11. Estimated life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n1. History of allergy to any component of the cell product;\n2. Any of the following hematologic abnormalities on complete blood count (CBC): WBC ≤ 1 × 10\\^9\u002FL, absolute neutrophil count (ANC) ≤ 0.5 × 10\\^9\u002FL, absolute lymphocyte count (ALC) ≤ 0.5 × 10\\^9\u002FL, or platelets (PLT) ≤ 25 × 10\\^9\u002FL;\n3. Any of the following laboratory abnormalities, including but not limited to: serum total bilirubin ≥ 1.5 mg\u002FdL; serum ALT or AST \\> 2.5 × ULN; serum creatinine ≥ 2.0 mg\u002FdL;\n4. NYHA class III or IV heart failure per the New York Heart Association functional classification, or left ventricular ejection fraction (LVEF) \\\u003C 50% on echocardiography;\n5. Abnormal pulmonary function with oxygen saturation (SpO₂) \\\u003C 92% on room air;\n6. History of myocardial infarction, coronary angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;\n7. Grade 3 hypertension with poor blood pressure control despite medical treatment;\n8. History of traumatic brain injury, disturbance of consciousness, epilepsy, or severe cerebral ischemic or hemorrhagic disease;\n9. Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy;\n10. Presence of uncontrolled active infection;\n11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;\n12. Receipt of a live vaccine within 4 weeks prior to enrollment;\n13. Positive test results for HIV, HBV, HCV, and TPPA\u002FRPR, and\u002For HBV carriers;\n14. History of alcohol abuse, illicit drug use, or psychiatric disorders;\n15. Participation in any other clinical study within 3 months prior to enrollment;\n16. Female subjects meeting any of the following:\n\n    1. pregnant or breastfeeding; or\n    2. planning pregnancy during the study period; or\n    3. of childbearing potential and unable\u002Funwilling to use effective contraception;\n17. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.",{"count":74,"type":22},[25,26],"1. Study Title:\n\n   Efficacy and safety of MSLN CAR-T in advanced malignant tumors\n2. Study Objectives:\n\n   Primary: To evaluate the safety and tolerability of MSLN-targeted CAR-T cell therapy in patients with stage III\u002FIV advanced malignant tumors.\n\n   Secondary: To preliminarily evaluate the efficacy of MSLN-targeted CAR-T cell therapy in this patient population.\n\n   Exploratory: To assess in vivo expansion and persistence of infused MSLN-targeted CAR-T cells and explore correlations with clinical outcomes.\n3. Participant Intervention:\n\nParticipants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and\n\n-3 relative to the planned MSLN CAR-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.",[97],"Advanced Solid Malignant Tumors (With Positive Expression of MSLN in Tumor Tissue)","2026-02-03",{"date":100,"type":36},"2026-02-10",{"date":102,"type":36},"2024-01-01",{"date":104,"type":22},"2027-01-30",{"name":42,"class":43},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":44},"100600416","phase-1-efficacy-and-safety-of-cd19cd20-carp40-t-in-b-cell-lymphoma-100600416","NCT07097207","Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma","Study on the Efficacy and Safety of Autocrine p40 Chimeric Antigen Receptor T Cells Targeting CD19 and CD20 (CD19CD20-CAR.p40-T) in Refractory B-Cell Lymphoma","CAR-T","Inclusion Criteria:\n\n1. Aged between 15 and 75 years old, regardless of gender;\n2. Diagnosed with relapsed\u002Frefractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;\n4. Expected survival time of ≥ 3 months;\n5. Confirmation of CD20 expression in tumor cells by flow cytometry\u002Fimmunohistochemistry;\n6. Patients tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;\n7. No severe heart, lung, liver, or kidney diseases;\n8. Capable of understanding and willing to sign the informed consent form for this trial;\n9. No contraindications to peripheral blood apheresis for the subject;\n10. Having clearly measurable and evaluable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard;\n11. The subject must have received standard first- and second-line treatment regimens;\n12. Not having received antibody-based drug treatment within 2 weeks before cell therapy.\n\nExclusion Criteria:\n\n1. History of allergy to any component in the cell product;\n2. The following conditions in the blood routine examination: White blood cell count (WBC) ≤ 1×10⁹\u002FL, absolute neutrophil count (ANC) ≤ 0.5×10⁹\u002FL, absolute lymphocyte count (ALC) ≤ 0.5×10⁹\u002FL, platelet count (PLT) ≤ 25×10⁹\u002FL;\n3. The following conditions in laboratory tests: including but not limited to, total serum bilirubin ≥ 1.5 mg\u002Fdl; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the upper limit of normal; serum creatinine ≥ 2.0 mg\u002Fdl;\n4. Patients with heart failure classified as grade III or IV according to the New York Heart Association (NYHA) classification criteria; or left ventricular ejection fraction (LVEF) \\\u003C 50% as detected by echocardiography;\n5. Abnormal lung function with oxygen saturation \\\u003C 92% under room air;\n6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically severe heart diseases within 12 months before enrollment;\n7. Grade 3 hypertension with poorly controlled blood pressure despite drug treatment;\n8. History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia or intracerebral hemorrhagic diseases;\n9. Patients with autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive agent treatment;\n10. Presence of uncontrolled active infection;\n11. Previous use of any CAR-T cell product or other genetically modified T cell therapies;\n12. Vaccination with live vaccines within 4 weeks before enrollment;\n13. Subjects positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Treponema pallidum particle agglutination assay (TPPA)\u002Frapid plasma reagin (RPR), as well as HBV carriers;\n14. History of alcohol abuse, drug abuse, or mental illness in the subject;\n15. The subject participated in any other clinical study within 3 months before joining this clinical study;\n16. Female subjects with any of the following conditions: a) Currently pregnant or breastfeeding; or b) Having a pregnancy plan during the trial period; or c) Being fertile but unable to take effective contraceptive measures;\n17. Other circumstances that, in the opinion of the investigator, make the subject unsuitable for participation in this study.",{"count":74,"type":22},[25,26],"1. Study Title:\n\n   A Study on the Efficacy and Safety of Autocrine p40 CD19\u002FCD20 Dual-Targeting Chimeric Antigen Receptor T-Cells (CD19\u002FCD20-CAR.p40-T) in Relapsed\u002FRefractory B-Cell Lymphoma\n2. Study Objectives:\n\n   * Primary Objective: To evaluate the safety of CD19\u002FCD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed\u002Frefractory B-cell lymphoma.\n   * Secondary Objective: To evaluate the efficacy of CD19\u002FCD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed\u002Frefractory B-cell lymphoma.\n3. Participant Intervention:\n\n   * Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19\u002FCD20-CAR.p40-T cell infusion or CD19 CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.",[78],"2025-07-24",{"date":120,"type":36},"2025-07-31",{"date":122,"type":36},"2023-10-01",{"date":124,"type":22},"2026-09-30",{"name":42,"class":43},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":44},"100565612","phase-1-bcma-gprc5d-car-t-therapy-in-relapsed-or-refractory-multiple-myeloma-100565612","NCT06644443","BCMA-GPRC5D CAR-T Therapy in Relapsed or Refractory Multiple Myeloma","BCMA-GPRC5D CAR-T Therapy in Relapsed or Refractory Multiple Myeloma：A Prospective, Single-center, Single-arm Phase I\u002FIIa Clinical Trial","Inclusion Criteria:\n\n1. Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited;\n2. The subject voluntarily participates in the research and signs the \\"Informed Consent\\" by himself or his legal guardian;\n3. Definitely diagnosed as relapsed or refractory multiple myeloma: use chemotherapy regimens containing bortezomib, or chemotherapy regimens containing lenalidomide, the treatment is ineffective, or the disease progresses within 60 days after the end of the last chemotherapy;\n4. The patient has one or more measurable multiple myeloma lesions, which must include any of the following:1) Serum M protein is greater than or equal to 0.5g \u002F dl (10g \u002F l) 2) Urine M protein is greater than or equal to 200 mg \u002F 24 h serum FLC ratio is abnormal 3) Serum free light chain (FLC) ≧5 mg \u002F dL (50 mg \u002FL) 4) Plasmacytoma that can be measured by physical examination or imaging examination 5) Myeloma cells in bone marrow ≧10% by flow cytometry or immunohistochemical examination\n5. After flow cytometry or immunohistochemical examination, myeloma cells have positive BCMA and GPRC5D expression;\n6. No salvage chemotherapy was used within 4 weeks before cell therapy;\n7. No antibody drug therapy was used within 2 weeks before cell therapy;\n8. The ECOG score is 0-2 points;\n9. The subject has no contraindications to peripheral blood apheresis;\n10. The expected survival period is ≧12 weeks;\n11. Female subjects of childbearing age must have a negative urine pregnancy test within 7 days prior to cell therapy and not during the lactation period; female or male subjects of childbearing age must take effective contraceptive measures throughout the study\n\nExclusion Criteria:\n\n1. Those who have a history of allergies to any of the ingredients in cell products;\n2. The following conditions in laboratory tests: including but not limited to serum total bilirubin ≥ 1.5 mg\u002Fdl; serum ALT or AST greater than 2.5 times the upper limit of normal; blood creatinine ≥ 2.0 mg\u002Fdl; hemoglobin\\\u003C80g\u002Fl; does not rely on GCSF or other growth factors, the absolute neutrophil count is less than 1000 \u002F mm3; no blood transfusion is required, and the platelet count is less than 30,000 \u002F mm3;\n3. According to the New York Heart Association (NYHA) cardiac function classification standards, patients with grade III or IV cardiac insufficiency; or echocardiographic examination of left ventricular ejection fraction (LVEF) \\\u003C50%;\n4. Abnormal lung function, blood oxygen saturation in indoor air\\\u003C92%;\n5. Myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious clinical heart diseases within 12 months before enrollment;\n6. Hypertension is grade 3 and the blood pressure is not well controlled by medication;\n7. Patients with prolonged QT interval on ECG, patients with severe heart disease such as severe arrhythmia in the past;\n8. Previously suffering from head injury, disturbance of consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;\n9. Need to use any anticoagulant (except aspirin);\n10. Patients who need urgent treatment due to tumor progression or spinal cord compression;\n11. Patients with CNS metastasis or CNS involvement symptoms (including cranial neuropathy and extensive disease or spinal cord compression);\n12. The investigator determines that there are serious complications or diseases that increase the risk of the subject or affect the research, including but not limited to, for example: liver cirrhosis, recent major trauma, etc.;\n13. After allogeneic hematopoietic stem cell transplantation;\n14. Plasma cell leukemia;\n15. Before apheresis and within 2 weeks before CAR-T cell infusion, apply more than 5 mg\u002Fd of prednisone (or an equivalent amount of other corticosteroids);\n16. Patients with autoimmune diseases, immunodeficiencies or other patients who need immunosuppressive therapy;\n17. There is an uncontrolled active infection;\n18. Live vaccination within 4 weeks before enrollment;\n19. HIV, HBV, HCV and TPPA\u002FRPR infected persons, and HBV carriers;\n20. The subject has a history of alcoholism, drug abuse or mental illness;\n21. The subject has participated in any other clinical research within 3 months before joining this clinical research;\n22. The researcher believes that the subjects have other conditions that are not suitable for participating in this study.",{"count":21,"type":22},[25,26],"At present, MM is still an incurable disease in general, and the vast majority of patients will eventually face disease recurrence or progression. Although CAR-T therapy targeting BCMA has shown advantages in the efficacy and safety of MM, for MM patients with BCMA negative or BCMA low expression, they still relapse after receiving targeted BCMA CAR T-cell therapy, and there is a problem of target escape. The specific high expression of GPRC5D in multiple myeloma cells makes it possible to combine BCMA and GPRC5D in the treatment of MM. This study aims to investigate the safety and efficacy of BCMA-GPRC5D CAR-T therapy in the treatment of relapsed or refractory MM.",[137],"Multiple Myeloma in Relapse",[139,140,141,142,143,144,145,146,147,148,149,150,151,152],"Neoplasms by Histologic Type","Neoplasms","Hemostatic Disorders","Vascular Diseases","Cardiovascular Diseases","Paraproteinemias","Blood Protein Disorders","Hematologic Diseases","Hemorrhagic Disorders","Lymphoproliferative Disorders","Immunoproliferative Disorders","Immune System Diseases","Multiple Myeloma","Neoplasms, Plasma Cell","2024-10-14",{"date":155,"type":36},"2024-10-16",{"date":157,"type":36},"2023-07-15",{"date":159,"type":22},"2026-07-14",{"name":42,"class":43},{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":44},"100534072","phase-2-comparing-astragalus-plus-gemcitabine-to-gemcitabine-alone-as-neoadjuvant-treatment-for-pancreatic-cancer-patients-100534072","NCT06234072","Comparing Astragalus Plus Gemcitabine to Gemcitabine Alone as Neoadjuvant Treatment for Pancreatic Cancer Patients","Comparison of Neoadjuvant Treatment for Pancreatic Cancer: Astragalus Combined With Gemcitabine Versus Gemcitabine Alone - A Single-Center, Randomized, Double-Blind Study","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma;\n* Is 18 years of age or older;\n* ECOG performance status 0 to 2;\n\nPatient organ function tests must meet the following laboratory parameters:\n\n* Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times the upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastasis, then AST (SGOT) and ALT (SGPT) may be ≤ 5 times ULN.\n* Total serum bilirubin ≤ 3.0 times ULN (if due to underlying liver metastasis, then total bilirubin may be ≤ 5 times ULN),\n* Neutrophils 1,500\u002FUl,\n* hemoglobin \\> 8.0 gm\u002FdL,\n* Platelet count ≥ 100,000\u002Fmm3 (IU: ≥ 100 x 109\u002FL),\n* serum creatinine \\\u003C 2.0 mg\u002FdL,\n* Expected postoperative survival ≥ 3 months;\n* Ability to comply with the study visit plan and other protocol requirements;\n* Voluntary participation and signing of informed consent.\n* Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* CNS damage or soft meningeal disease;\n* Metastasis to distant sites;\n* Other serious diseases or conditions, including congestive heart failure (New York Heart Association class III or IV), unstable angina pectoris, infarction in the past 6 months, severe arrhythmia, prolonged QT interval, active HIV infection or HIV disease, mental disorders, and substance abuse;\n* Known hypersensitivity to Astragalus or gemcitabine;\n* Pregnant or lactating women. Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception throughout the treatment period of this trial and for 12 weeks after the last dose of study drug. Sexually active, fertile men who are not using effective contraception themselves if their partner is a woman of childbearing potential;\n* Known neuroendocrine tumor of the pancreas;\n* Receiving a concomitant treatment with drugs interacting with gemcitabine;\n* Past or concurrent cancers with primary foci or histology completely different from pancreatic cancer, except for cervical cancer in situ, previously treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis \\& T1). Any cancer cured \\>5 years prior to enrollment is allowed;\n* Inability to swallow herbal medicines or untreated malabsorption syndrome and unwillingness to take herbal medicines.\n* Patients with poor compliance",{"count":169,"type":22},120,[26],"This study compare the efficacy of Astragalus combined with Gemcitabine to Gemcitabine alone as neoadjuvant treatment for pancreatic cancer.",[173],"Pancreatic Cancer","NOT_YET_RECRUITING","2024-01-31",{"date":177,"type":36},"2024-02-02",{"date":179,"type":22},"2024-02",{"date":181,"type":22},"2027-01",{"name":42,"class":43},{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":190,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":44},"100486950","treatment-of-advanced-malignant-solid-tumors-with-claudin182car-t-100486950","NCT05620732","Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T","Efficacy and Safety of Claudin18.2CAR-T in Advanced Pancreatic Cancer and Gastric Carcinoma","Inclusion Criteria:\n\n1. Age 18-75 (≥ 18, ≤ 75), regardless of gender;\n2. Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form;\n3. Non resectable, locally late recurrent or metastatic gastric cancer or pancreatic cancer confirmed by histopathology; Patients with gastric cancer or pancreatic cancer diagnosed as stage III or IV according to the TNM staging system of the American Joint Commission on Cancer (AJCC) (8th edition in 2017);\n4. According to RECIST 1.1 standard, there are clearly measurable and evaluable lesions;\n5. Immunohistochemical staining confirmed that Claudin 18.2 was moderately and highly expressed in tumor tissues;\n6. Subjects must have received the first and second line standard treatment scheme;\n7. The subject must not be suitable for receiving radical treatment methods, such as radical chemotherapy and radiotherapy and\u002For surgery\u002Fimmunosuppressant at the checkpoint, or refuse surgical resection\n8. Within 2 weeks before cell therapy, no antibody drugs were used;\n9. ECOG score is 0-2;\n10. The subjects had no contraindication for peripheral blood collection;\n11. The expected survival period is more than 3 months.\n\nExclusion Criteria:\n\n1. People who have a history of allergy to any component in cell products;\n2. The following conditions occur in blood routine examination: WBC ≤ 1 × 109\u002FL, absolute value of central granulocyte ANC ≤ 0.5 × 109\u002FL, absolute value of lymphocyte ALC ≤ 0.5 × 109\u002FL , PLT≦25 × 109\u002FL ；\n3. The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg\u002Fdl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg\u002Fdl;\n4. According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)\\\u003C50% by echocardiography;\n5. Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%;\n6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment;\n7. Grade 3 hypertension and poor blood pressure control after drug treatment;\n8. Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past;\n9. Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment;\n10. There is uncontrolled active infection;\n11. Have used any CAR-T cell product or other genetically modified T cell therapy before;\n12. Live vaccine inoculation within 4 weeks before enrollment;\n13. HIV, HBV, HCV and TPPA\u002FRPR positive persons, and HBV carriers;\n14. Subjects have a history of alcohol abuse, drug abuse or mental illness;\n15. Subjects have participated in any other clinical research within 3 months before joining this clinical research;\n16. Female subjects have any of the following conditions: a) are in pregnancy\u002Flactation; Or b) having a pregnancy plan during the trial; Or c) is fertile and unable to take effective contraceptive measures;\n17. The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study",{"count":74,"type":22},[192],"NA","The efficacy of advanced pancreatic cancer and gastric cancer needs to be further improved. Claudin is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in gastric cancer and pancreatic cancer. Preclinical studies suggest that Claudin18.2CAR-T can effectively improve the remission rate of patients with advanced solid tumors.",[195,196],"Advanced Pancreatic Carcinoma","Advanced Gastric Carcinoma","2022-11-17",{"date":199,"type":36},"2022-11-22",{"date":201,"type":36},"2022-10-01",{"date":203,"type":22},"2028-10-31",{"name":42,"class":43},{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":212,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":44},"100486947","study-of-ny-eso-1-tcr-t-in-advanced-soft-tissue-sarcoma-100486947","NCT05620693","Study of NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma","Study NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Aged 18-70 (≥ 18, ≤ 70), regardless of gender;\n2. Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form;\n3. Late recurrent or metastatic soft tissue sarcoma confirmed by histopathology; Progress after receiving first-line treatment;\n4. According to RECIST 1.1 standard, there are clear assessable lesions;\n5. The expression of NY-ESO-1 in tumor tissue was confirmed by immunohistochemical staining; HLA-A configuration is 02\u002F01;\n6. Within 2 weeks before cell therapy, no antibody drugs were used;\n7. ECOG score is 0-2;\n8. The subject has no contraindication for peripheral blood collection;\n9. The expected survival period is more than 3 months.\n\nExclusion Criteria:\n\n1. People who have a history of allergy to any component in cell products;\n2. The following conditions occur in blood routine examination: WBC ≤ 1 × 109\u002FL, absolute value of neutrophil ANC ≤ 0.5 × 109\u002FL, absolute value of lymphocyte ALC ≤ 0.5 × 109\u002FL , PLT≦25 × 109\u002FL ；\n3. The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg\u002Fdl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg\u002Fdl;\n4. According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)\\\u003C50% by echocardiography;\n5. Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%;\n6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment;\n7. Grade 3 hypertension and poor blood pressure control after drug treatment;\n8. Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past;\n9. Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment;\n10. There is uncontrolled active infection;\n11. Have used any cell therapy products in recent 3 months;\n12. Live vaccine inoculation within 4 weeks before enrollment;\n13. HIV, HBV, HCV and TPPA\u002FRPR positive persons, and HBV carriers;\n14. Subjects have a history of alcohol abuse, drug abuse or mental illness;\n15. Subjects have participated in any other clinical research within 3 months before joining this clinical research;\n16. Female subjects have any of the following conditions: a) are in pregnancy\u002Flactation; Or b) having a pregnancy plan during the trial; Or c) is fertile and unable to take effective contraceptive measures;\n17. The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study.",{"count":74,"type":22},[192],"Soft tissue sarcoma (STS) is a kind of solid tumor with high heterogeneity. There is no standard second-line treatment plan for patients who have failed first-line treatment. NY-ESO-1, a cancer testis antigen, is highly expressed in soft tissue tumors and is an ideal therapeutic target.\n\nInvestigators aim to testify the safety and efficacy of NY-ESO-1 TCR-T cell in advanced soft tissue sarcoma.",[216],"Advanced Soft-tissue Sarcoma",{"date":199,"type":36},{"date":219,"type":36},"2022-11-11",{"date":221,"type":22},"2028-12-01",{"name":42,"class":43},{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":230,"maxAge":52,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":240,"locationsCount":44},"100486948","study-of-gpc-3-car-t-cells-in-treating-with-hepatocellular-carcinoma-100486948","NCT05620706","Study of GPC-3 CAR-T Cells in Treating With Hepatocellular Carcinoma","Study of GPC-3 CAR-T Cells in Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. 40\\~70 years old;\n2. Patients with advanced hepatocellular carcinoma (HCC) diagnosed by histopathology or cytology, who are not suitable for surgery or local treatment (including ablation therapy, interventional therapy and radiotherapy), and who have experienced progress or intolerance after receiving standard treatment in the past;\n3. Patients who have been terminated for more than 28 days due to previous ineffective PD-1 monoclonal antibody treatment;\n4. At least one target lesion that can be evaluated stably according to RECIST 1.1 standard is defined as: the longest diameter of non lymph node lesions ≥ 10mm, or the short diameter of lymph node lesions ≥ 15mm; Intrahepatic lesions require enhanced imaging in arterial phase;\n5. Tumor tissue samples were positive for GPC3 by immunohistochemistry (IHC);\n6. Grade C according to Barcelona liver cancer grading standard (BCLC) or Grade B which is not suitable for local treatment\u002Fprogression of local treatment;\n7. Estimated survival time \\> 12 weeks;\n8. Cirrhotic state Child Pugh score Grade A\n9. ECOG physical status score 0\\~1;\n10. If the patient is HBsAg positive or HBcAb positive, HBV-DNA\\\u003C200IU\u002Fml. HBsAg positive patients must receive antiviral treatment according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015);\n11. Single vein access;\n12. Blood routine test: WBC ≥ 2.5 × 109\u002FL， PLT≥60 × 109\u002FL， Hb≥9.0 g\u002FdL，LY≥0.4 × 109\u002FL；\n13. Blood biochemistry: serum Alb ≥ 30 g\u002FL, serum lipase and amylase ≤ 1.5 ULN, serum creatinine ≤ 1.5 ULN and endogenous creatinine clearance rate ≥ 40mL\u002Fmin, ALT ≤ 5ULN, AST ≤ 5ULN, total bilirubin ≤ 2.5ULN, prothrombin time extension ≤ 4s;\n14. The women of childbearing age must carry out serum pregnancy test within the screening period and 14 days before starting the study medication, and the result is negative. They are willing to use reliable methods of contraception during the test period (within 12 months (M12) after cell infusion); For male subjects whose partners are women of childbearing age, they should have undergone sterilization or agree to use reliable methods of contraception during the trial\n15. Be able to understand and sign the informed consent form\n\nHBsAg positive patients must receive antiviral treatment according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015);\n\n11\\. Single vein access;\n\n12\\. Blood routine test: WBC ≥ 2.5 × 109\u002FL， PLT≥60 × 109\u002FL， Hb≥9.0 g\u002FdL，LY≥0.4 × 109\u002FL；\n\n13\\. Blood biochemistry: serum Alb ≥ 30 g\u002FL, serum lipase and amylase ≤ 1.5 ULN, serum creatinine ≤ 1.5 ULN and endogenous creatinine clearance rate ≥ 40mL\u002Fmin, ALT ≤ 5ULN, AST ≤ 5ULN, total bilirubin ≤ 2.5ULN, prothrombin time extension ≤ 4s;\n\n14\\. The women of childbearing age must carry out serum pregnancy test within the screening period and 14 days before starting the study medication, and the result is negative. They are willing to use reliable methods of contraception during the test period (within 12 months (M12) after cell infusion); For male subjects whose partners are women of childbearing age, they should have undergone sterilization or agree to use reliable methods of contraception during the trial\n\n15\\. Be able to understand and sign the informed consent form\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. HCV-RNA, HIV antibody or syphilis antibody are positive;\n3. Any uncontrollable active infection, including but not limited to active tuberculosis;\n4. Have received systemic steroids equivalent to\\>15 mg prednisone within 2 weeks before single collection, except inhaled steroids;\n5. Allergies to immunotherapy and related drugs, previous severe allergies β- Allergy to lactam antibiotics;\n6. Previous or current hepatic encephalopathy;\n7. At present, there is ascites with clinical significance, which is defined as: ascites with positive signs on physical examination or ascites that need to be controlled by intervention (such as puncture or drug therapy) (only those with ascites shown on imaging without intervention can be included);\n8. Imaging examination results: the proportion of liver being replaced by tumor ≥ 50%, or portal trunk tumor thrombus, or tumor thrombus invading mesenteric vein\u002Finferior vena cava;\n9. Central nervous system metastasis and diseases of central nervous system with clinical significance;\n10. At present, there is a heart disease that needs treatment or hypertension that is judged by the researcher to be poorly controlled (systolic blood pressure\\>160mmHg or diastolic blood pressure\\>100mmHg);\n11. Patients with known active autoimmune diseases need to be treated with immunosuppressants including biological agents;\n12. Patients with a history of organ transplantation or waiting for organ transplantation (including liver transplantation);\n13. Have received treatment for the study disease within 2 weeks before single collection, including but not limited to surgical treatment, interventional treatment, radiotherapy, chemotherapy and immunotherapy;\n14. Received targeted GPC3 treatment, TCR-T treatment and CAR-T treatment in the past month;\n15. Being treated with anti PD-1\u002FPD-L1 monoclonal antibody in the past 28 days;\n16. Other incurable malignant tumors in the past 5 years or at the same time, excluding cervical carcinoma in situ and skin basal cell carcinoma;\n17. Other serious diseases that may restrict the subjects from participating in this trial (such as diabetes under poor control (HbA1c\\>7% after treatment), severe cardiac insufficiency (LVEF\\\u003C45%), myocardial infarction or unstable arrhythmia or unstable angina pectoris in the last 6 months, pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung disease Pulmonary function test FEV1 accounts for less than 60% of the estimated value, gastric ulcer, history of gastrointestinal bleeding disease or clear gastrointestinal bleeding tendency);\n18. The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol.","40 Years",{"count":74,"type":22},[192],"Hepatocellular carcinoma is a highly heterogeneous disease. Treatment strategies for advanced hepatocellular carcinoma are limited. Phosphatidylinositol proteoglycan 3 (GPC3) is a heparan sulfate glycoprotein (HSPG) on the surface of the cell membrane. It is highly expressed in liver cancer tissues, but hardly expressed in normal liver tissues. It is an ideal target for tumor treatment. Investigators aimed to test the safety and efficacy of GPC3 CAR-T cells in patients with advanced hepatocellular carcinoma.",[235],"Advanced Hepatocellular Carcinoma",{"date":199,"type":36},{"date":238,"type":36},"2022-11-01",{"date":203,"type":22},{"name":42,"class":43},{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":255,"leadSponsor":256,"locationsCount":44},"100486946","cd7-car-t-cells-in-t-cell-lymphomaleukemia-100486946","NCT05620680","CD7 CAR-T Cells in T-cell Lymphoma\u002FLeukemia","Study of CD7 CAR-T Cells in Adult Refractory and Recurrent T-cell Lymphoma\u002FLeukemia","Inclusion Criteria:\n\n1. Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited;\n2. The subject voluntarily participates in the research and signs the \"Informed Consent\" by himself or his legal guardian;\n3. According to the National Comprehensive Cancer Network (NCCN) T lymphocytic lymphoma (2020.V1)\u002Facute lymphoblastic leukemia (2020. V1) practice guidelines, diagnosed with T-cell lymphoma;\n4. Meet the diagnostic criteria for relapsed\u002Frefractory T-cell lymphoma, including any of the following:\n\n1\\) Failure to obtain CR at the end of induction therapy; 2) Patients who have obtained CR have blasts in peripheral blood or bone marrow (proportion \\>5%), or extramedullary diseases; 5. Have not received antibody therapy within 2 weeks before cell therapy; 6. ECOG score of 0-2; 7. The subject has no contraindications to peripheral apheresis; 8. Expected survival time of more than 3 months.\n\nExclusion Criteria:\n\n1. Those who have a history of allergy to any of the ingredients in cell products;\n2. Laboratory tests for the following: including but not limited to, total serum bilirubin≧ 1.5mg\u002Fdl; Serum ALT or AST greater than 2.5 times the upper limit of normal; Blood creatinine≧ 2.0mg\u002Fdl; Platelet count≦ 10×109\u002FL;\n3. Patients with cardiac insufficiency who belong to class III or IV according to the New York Cardiology Association (NYHA) cardiac function grading standards; or echocardiography with left ventricular ejection fraction (LVEF) \\\u003C 50%;\n4. Abnormal lung function, blood oxygen saturation under indoor air \\\u003C 92%;\n5. Myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other serious clinical heart disease within 12 months before enrollment;\n6. Grade 3 hypertension with poor control of blood pressure with medication;\n7. Patients with other advanced tumors (those who are assessed as stable after treatment of other tumors can be enrolled);\n8. Previous head trauma, impaired consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;\n9. Known central nervous system leukemia (CNS2 or CNS3), resistance to intrathecal chemotherapy injections and\u002For ongoing head and\u002For spinal radiation therapy; Previous CNS history but has been effectively controlled to allow enrollment;\n10. Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressant therapy;\n11. presence of uncontrolled, active infection;\n12. Have previously used any CAR-T cell product or other genetically modified T cell therapy;\n13. Live vaccination within 4 weeks prior to enrollment;\n14. HIV, HBV, HCV and TPPA\u002FRPR infections, and HBV carriers;\n15. Subject has a history of alcoholism, drug addiction or mental illness;\n16. The subject has participated in any other clinical research within 3 months before joining this clinical study;\n17. Female subjects have any of the following conditions: a) are pregnant\u002Flactating; or b) have plans to become pregnant during the trial; or c) are of childbearing potential and unable to use effective contraception;\n18. There are other circumstances in which the investigator believes that the subject is not suitable for this study.",{"count":74,"type":22},[192],"T-cell lymphoma\u002Fleukemia is a group of highly lethal diseases with a high relapse rate and poor prognosis. CD7 was proved to be widely expressed in T-cell malignant, which makes it a promising therapeutic target.\n\nIn this study we aim to test the safety and efficacy of CD7 CAR-T cells in T-cell lymphoma\u002Fleukemia.",[252],"T Lymphoblastic Leukemia\u002FLymphoma",{"date":197,"type":36},{"date":201,"type":36},{"date":203,"type":22},{"name":42,"class":43},""]