[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640520":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":46,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":19,"overallStatus":31,"whyStopped":19,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Shenzhen University General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CART group","EXPERIMENTAL","Participants 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.",[13],"Combination Product: CAR-T cell",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"COMBINATION_PRODUCT","CAR-T cell",[9],null,[21],{"name":22,"affiliation":5,"role":23},"lixin wang, PHD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","0755-21839999","wanglixin1991@sohu.com",[30],{"facility":5,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Shenzhen","Other (Non U.s.)","518055","China","CN",{"type":38,"coordinates":39},"Point",[40,41],114.0683,22.54554,{"lat":41,"lon":40},[44,45],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","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":60,"type":61},10,"ESTIMATED","INTERVENTIONAL",[64,65],"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.",[68,69,70],"B Cell Lymphoma","Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","2026-05-07",{"date":73,"type":74},"2026-05-13","ACTUAL",{"date":76,"type":74},"2024-04-20",{"date":78,"type":61},"2029-04-19",{"name":5,"class":6},1]