[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618705":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":13,"centralContacts":34,"locations":13,"responsibleParty":41,"collaborators":13,"id":45,"slug":13,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":13,"eligibilityCriteria":49,"healthyVolunteers":46,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":13,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":65,"whyStopped":13,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":13},{"fullName":5,"class":6},"Zhujiang Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"ORR","Objective response rates (ORR), including CR and PR, were analyzed by Clopper-Pearson distribution with bilateral 95% confidence intervals. For progression-free survival (PFS), Kaplan-Meier method was used to estimate the survival curve. Overall survival: the time from cell retransfusion until death from any cause.","3 years",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Objective: To evaluate the 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. Secondary objective: To evaluate the efficacy and cytodynamics of humanized CD19 CAR-T therapy with TLR2 in adult acute B lymphoblastic leukemia\u002Flymphoma who cannot tolerate intense chemotherapy at initial treatment.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"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.",[27],"Biological: humanized CD19 CAR-T Cells with TLR2",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"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",[23],[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Yuhua LI, Ph.D.","CONTACT","+8613533706656","15626020982","812843798@qq.com",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Li Yuhua","professor","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":54,"type":55},60,"ESTIMATED","INTERVENTIONAL",[58],"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.",[61],"B Lymphoblastic Leukemia\u002FLymphoma",[63,64],"CAR-T","CD19","NOT_YET_RECRUITING","2026-01-04",{"date":68,"type":69},"2026-01-12","ACTUAL",{"date":71,"type":55},"2026-06-01",{"date":73,"type":55},"2029-06-01",{"name":5,"class":6}]