[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618705":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":28,"collaborators":20,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":36,"acronym":20,"eligibilityCriteria":37,"healthyVolunteers":34,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":20,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":53,"whyStopped":20,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":20},{"fullName":5,"class":6},"Zhujiang Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Arm","EXPERIMENTAL","Administer a single infusion of humanized CD19 CAR-T Cells with TLR2 to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion, and conduct follow-up surveys at the required time points within three years post-infusion according to the visit schedule.",[13],"Biological: humanized CD19 CAR-T Cells with TLR2",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","humanized CD19 CAR-T Cells with TLR2","Administer a single infusion of humanized CD19 CAR-T Cells with TLR2 to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Yuhua LI, Ph.D.","CONTACT","+8613533706656","15626020982","812843798@qq.com",{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Li Yuhua","professor","100618705","early-phase-1-a-clinical-study-of-humanized-cd19-car-t-cells-with-tlr2-for-the-treatment-of-adult-patients-with-naive-b-cell-acute-lymphoblastic-leukemialymphoma-who-are-intolerant-to-intensive-chemotherapy-100618705",false,"NCT07335094","A Clinical Study of Humanized CD19 CAR-T Cells With TLR2 for the Treatment of Adult Patients With Naive B-Cell Acute Lymphoblastic Leukemia\u002FLymphoma Who Are Intolerant to Intensive Chemotherapy","Inclusion Criteria:\n\n1. Newly treated patients with acute B-lymphocytic leukaemia\u002Flymphoma who are clinically determined to be unable to tolerate strong chemotherapy;\n2. age 18-80 years old (including boundary value), both men and women can;\n3. The physical status of the American Eastern Cancer Collaboration Group (ECOG) was 0\\~2 points;\n4. Positive CD19 confirmed by flow cytometry and\u002For histopathology;\n5. The expected survival period from the date of signing the informed consent form is more than 3 months.；\n6. women of childbearing age screening period human chorionic gonadotropin (HCG) test negative, and Consent to use contraception for at least 1 year after the infusion; A man whose partner is fertile Subjects must agree to use an effective barrier contraceptive method for at least 1 year after the infusion；\n7. the patient's main tissues and organs function well: (1) Liver function: ALT\u002FAST\\\u003C3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol\u002FL; (2) Renal function: creatinine clearance (Cockcroft-Gault method) ≥60mL\u002Fmin; (3) Lung function: blood oxygen saturation ≥95%, and no active lung infection; (4) Cardiac function: left ventricular ejection fraction (LVEF) ≥50%; No large number of pericardium was found Fluid accumulation, no clinically significant electrocardiogram abnormalities；\n\nExclusion Criteria:\n\n1. severe cardiac insufficiency, left ventricular ejection fraction \\\u003C50%;\n2. have a history of severe lung function impairment;\n3. Combined with other advanced malignant tumors;\n4. Had severe infection within 4 weeks before enrollment and could not be effectively controlled;\n5. suffering from serious autoimmune diseases or immune deficiency diseases;\n6. active hepatitis (HBV DNA quantitative \\> 500IU\u002Fml\\] or HCV ribose Nucleic acid \\[HCVRNA\\] test positive);\n7. human immunodeficiency virus (HIV) infection or known to have acquired immunodeficiency syndrome Co-syndrom (AIDS), or syphilis infection;\n8. Have a history of severe allergy to biological products (including antibiotics), antibodies or cytokines Allergy to macromolecular biological drugs;\n9. Acute graft-versus-host reactions were still present one month after immunosuppressant discontinuation Patients with allogeneic hematopoietic stem cell transplantation (GvHD);\n10. in the pregnancy period (urine\u002Fblood pregnancy test positive) or breastfeeding women; nearly Men or women who plan to conceive within 1 year; Not guaranteed to be taken within 1 year after enrollment Effective contraception (condoms or contraceptives, etc.);\n11. History of clinically significant central nervous system diseases, such as epilepsy, paresis, and loss Speech, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic Cerebral syndrome;\n12. Suffering from mental illness;\n13. The patient has substance abuse\u002Faddiction;\n14. Use of banned drugs. (1). Hormones: within 7 days before leukocyte collection, or within 72 hours before CD19CAR-T administration A past therapeutic dose of corticosteroid (defined as prednisone or equivalent \\> 20mg\u002Fday) Days). However, the use of physiological substitutes, topical and inhaled steroids is permitted. (2) Chemotherapy: rescue chemotherapy was received within 2 weeks before white blood cell collection. (3) Allogeneic cell therapy: donor lymphocytes were received within 4 weeks before white blood cell collection Infusion. (4).GVHD treatment: Anti-GVHD received within 4 weeks prior to CD19CAR T cell infusion Heal. (5) Alenzumab was used within 6 months before white blood cell collection, or chlorine was used within 3 months Farabine or cladobine.","ALL","18 Years","80 Years",{"count":42,"type":43},60,"ESTIMATED","INTERVENTIONAL",[46],"EARLY_PHASE1","The purpose of this clinical trial is to tolerability and safety of humanized CD19 CAR-T therapy with TLR2 in adult patients with acute B lymphoblastic leukemia\u002Flymphoma who cannot tolerate intense chemotherapy at initial treatment. Participants will receive a single infusion of CD19 CAR-T and complete follow-ups over the next three years.",[49],"B Lymphoblastic Leukemia\u002FLymphoma",[51,52],"CAR-T","CD19","NOT_YET_RECRUITING","2026-01-04",{"date":56,"type":57},"2026-01-12","ACTUAL",{"date":59,"type":43},"2026-06-01",{"date":61,"type":43},"2029-06-01",{"name":5,"class":6}]