[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574394":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":33,"centralContacts":37,"locations":42,"responsibleParty":58,"collaborators":32,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":32,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":32,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":44,"whyStopped":32,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"The Third Affiliated Hospital of Southern Medical University","OTHER_GOV",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1:Low dose group","EXPERIMENTAL","Infusion of CAR T-cells by single dose of 0.5×10\\^6 CAR-T cells\u002Fkg",[13],"Biological: CAR-T",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1: Medium dose group","Infusion of CAR T-cells by single dose of 1.5×10\\^6 CAR-T cells\u002Fkg",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Phase 1: High dose group","Infusion of CAR T-cells by single dose of 5.0×10\\^6 CAR-T cells\u002Fkg",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Phase 2a: RP2D","After all subjects in the Phase 1 dose-escalation study completed DLT observation, RP2D was determined based on the analysis results for the phase 2a expansion study.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"BIOLOGICAL","CAR-T","CAR T-cell therapy involves autologous chimeric antigen receptor T-cells, capable of targeting human B cell maturation antigen (BCMA) ,CD19 or CD-7 etc. target molecules of other hematologic malignancies.",[19,15,9,23],null,[34],{"name":35,"affiliation":32,"role":36},"Yan Yi, MD.","STUDY_DIRECTOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":32,"email":41},"CONTACT","+86 13617493781","yiyan@smu.edu.cn",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Guangzhou","Guangdong","510630","China","CN",{"type":51,"coordinates":52},"Point",[53,54],113.25,23.11667,{"lat":54,"lon":53},[57],{"name":35,"role":39,"phone":40,"phoneExt":32,"email":41},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Yan Yi","MD.","100574394","phase-1-safety-and-efficacy-of-fourth-generation-car-t-in-the-treatment-of-hematologic-malignancies-100574394",false,"NCT06758713","Safety and Efficacy of Fourth-Generation CAR-T in the Treatment of Hematologic Malignancies","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1\\. Voluntarily participate in this clinical study and sign the informed consent form; 2. 18 to 75 years old (including cut-off value), Male and female;; 3. Expected survival of at least 3 months; 4.1 CD19-positive B lymphocyte-derived hematologic malignancies; 4.2 Multiple myeloma patients; 4.3 Non-B cell-derived hematologic malignancies patients with CD7 or other target molecules; 5. The clinical trial values during the screening period meet the following criteria:\n\n1. White blood cell count ≥ 3.0 × 10e9\u002FL; Absolute neutrophil ≥ 1.0 × 10e9\u002FL; Lymphocyte count ≥ 0.5 × 10e9\u002FL. (The growth factor support is allowed, but growth factor must not have been received within 7 days prior to laboratory testing);\n2. Platelet count ≥ 50 × 10e9\u002FL (No blood transfusion support within 7 days prior to laboratory tests.); Note: Patients with leukemia, multiple myeloma, and lymphoma are not subject to the above blood picture requirements;\n3. Biochemical indicators Serum total bilirubin (TBIL) ≤ 2.5 ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN, or 5 ULN if liver dysfunction is primarily due to tumor invasion); 6. Cardiac function: Subjects must have good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 55%; 7. Lung condition: Subjects are not serious infections such as severe pneumonia; 8. ECOG activity status score: 0-2 points; 9. Female subjects must use effective contraception (such as oral prescription contraceptives, injectable contraceptives, intrauterine devices, double blockade, contraceptive patches, male partner sterilization) throughout the study period; Must have a negative serum or urine pregnancy test result at screening and throughout the study.\n\nExclusion Criteria:\n\nAny one of the following conditions cannot be selected as a subject:\n\n1. Having received CAR-T therapy targeting the same molecule;\n2. Having received other immunotargeted therapy targeting the same molecules;\n3. Pregnant or lactating women;\n4. Subjects who have previously suffered from other malignancies, with the following exceptions:\n\n   1. Having received curative therapy, and no known active disease in the ≥ 3 years prior to the enrollment;\n   2. Non melanoma skin cancer subjects who have completed sufficient treatment and no evidence of thecurrent disease;\n5. Subjects with a severe mental disorder;\n6. Subjects with active autoimmune disease requiring immunotherapy;\n7. Having received allogeneic hematopoietic stem cell transplantation;\n8. Subjects with significant cardiovascular diseasesa.uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart disease with cardiac function grade 3 or grade 4 (according to the functional classification method of the New York Heart Association NYHA); b. Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening); c. Clinically significant history of ventricular arrhythmia or unexplained syncope (non vaso-vagal or not due to dehydration);\n9. Subjects with active infectious disease including positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and peripheral blood Hepatitis B virus(HBV) DNA titer is ≥500IU\u002FmL, hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive, human immunodeficiency virus(HIV) antibody positive, syphilis primary screening antibody positive, active pulmonary tuberculosis; or with any significant infection requiring high-grade antibiotics Event;\n10. Subjects with dysfunction of important organssuch as organ function in the following abnormalities:\n\n    1. Serum AST or ALT \\> 2.5×ULN, or \\> 5ULN if liver function is predominantly due to tumor invasion; TBIL \\> 2.5 × ULN, unless the subject is Gilbert's syndrome;\n    2. Serum creatinine\\>2.5mg\u002Fdl;\n    3. Partial prothrombin time or activated partial thromboplastin time or international normalized ratio \\> 1.5×ULN in the absence of anticoagulant therapy;\n11. Participation in other clinical studies or prior treatment with any gene therapy product in the past three months;\n12. Subjects with uncontrolled diabetes mellitus (glycosylated hemoglobin HbAlc \\>8% at screening);13. Highly allergic constitution or history of severe allergies, and having contraindications to cyclophosphamide or fludarabine;\n\n14\\. Feasibility assessment screening demonstrated \\\u003C10% transfection of targeted lymphocytes or underamplification under CD3 \u002F CD28 costimulation (\\\u003C5-fold); 15. Subjects who are considered unsuitable to participate in this trial by the investigator.","ALL","18 Years","75 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","This is a single center, open-label, dose-escalation\u002Fexpansion clinical study to evaluate the safety and effectiveness of Fourth-Generation CAR-T, and determine the recommended dose of the CAR T-cells for patients with Multiple Myeloma，B-cell lymphoma and other hematologic malignancies.",[79,80,81],"Multiple Myeloma","B-cell Lymphoma","Hematological Malignancy",[83,84,85,29,86,87],"Multiple myeloma","B-cell lymphoma","Hematological malignancy","Safety","Efficacy","2025-01-03",{"date":90,"type":91},"2025-01-06","ACTUAL",{"date":93,"type":73},"2025-01-15",{"date":95,"type":73},"2028-12-31",{"name":5,"class":6},1]