[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-lymphoblastic-leukemialymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-lymphoblastic-leukemialymphoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"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":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"B Lymphoblastic Leukemia\u002FLymphoma",[28,29],"CAR-T","CD19","NOT_YET_RECRUITING","2026-01-04",{"date":33,"type":34},"2026-01-12","ACTUAL",{"date":36,"type":20},"2026-06-01",{"date":38,"type":20},"2029-06-01",{"name":40,"class":41},"Zhujiang Hospital","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":5},"100539727","early-phase-1-the-safety-and-efficacy-of-rd06-03-cart-cell-injection-in-patients-with-rr-acute-b-lymphoblastic-leukemia-100539727","NCT06307600","The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R\u002FR Acute B-lymphoblastic Leukemia","The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With Relapsed or Refractory B-lymphoblastic Leukemia","Inclusion Criteria:\n\n* Aged ≥3 and ≤70 years, gender and race unrestricted.\n* Bone marrow examination confirms the diagnosis of acute B-cell lymphoblastic leukemia (B-ALL) and meets one of the following conditions:\n\nRelapsed B-ALL: ① Relapse within 12 months after the first remission; or ② Relapse after salvage chemotherapy in first-line\u002Fmulti-line treatment; or ③ Relapse after autologous or allogeneic hematopoietic stem cell transplantation; Refractory B-ALL: ① Failure to achieve complete remission after 2 cycles of standardized induction chemotherapy; or ② Failure to achieve complete remission after salvage chemotherapy in first-line\u002Fmulti-line treatment;\n\n* Ph+ALL subjects are eligible if they meet one of the following criteria: ① Relapse or refractory after receiving at least 2 tyrosine kinase inhibitors (TKIs) treatments; if accompanied by TKI-resistant mutations such as T315I\u002FA, V299L, F317L\u002FV\u002FI\u002FC, G250E, Y253H, E255K\u002FV, F359V\u002FC\u002FI, subjects are not required to receive at least two TKI treatments; or ② Unable to tolerate TKI treatment; or ③ Contraindications to TKI treatment.\n* The proportion of bone marrow blasts during the screening period is ≥5% (morphological).Expression of CD19 on bone marrow or peripheral blood tumor cells is detected during the screening period.\n* Organ function and laboratory tests meet the following criteria:\n\nSerum total bilirubin \\\u003C2× upper limit of normal (ULN), serum ALT and AST both \\\u003C3× ULN, serum creatinine \\\u003C1.5× ULN; Coagulation function: International normalized ratio (INR) ≤1.5× ULN, or prothrombin time (PT) ≤1.5× ULN; Transthoracic echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; Resting oxygen saturation (SpO2) ≥92% in ambient air; Estimated survival period of more than 3 months;\n\n* ECOG score 0-2;\n* Fertile women must agree to use highly effective contraception from at least 28 days before leukapheresis to 6 months after CAR-T cell infusion. Their partners, fertile men, must agree to use effective barrier contraception from the start of leukapheresis to 6 months after CAR-T cell infusion, and should not donate semen or sperm during the entire trial period.\n\nExclusion Criteria:\n\n* Suffering from genetic syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndromes;\n* History of allergy to any component of the cellular product;\n* Presence of active central nervous system leukemia (CNSL) at screening;\n* Patients with purely extramedullary relapse;\n* Received allogeneic hematopoietic stem cell transplantation (HSCT) within 3 months before screening or experienced grade II to IV active graft-versus-host disease (GVHD) within 4 weeks before infusion;\n* Significant cardiovascular dysfunction within 12 months before screening, including but not limited to: New York Heart Association (NYHA) class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias.\n\nPresence or suspicion of uncontrollable active infection requiring intravenous therapy (excluding simple urinary tract infections, bacterial pharyngitis);\n\n* Subjects with a history of other primary cancers, excluding the following:\n\nNon-melanoma skin cancers such as basal cell carcinoma that have been cured by resection; Cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ with disease-free survival ≥2 years after adequate treatment;\n\n* Subjects with autoimmune diseases requiring treatment, immunodeficiency, or requiring immunosuppressive therapy;\n* Received live attenuated vaccines within 4 weeks before screening, or planned to receive live attenuated vaccines during the study.","3 Years","70 Years",{"count":52,"type":20},9,[23],"This study is designed to explore the safety and efficacy for patients with relapsed and\u002For refractory B-cell lymphoblastic leukemia.",[26],"RECRUITING","2025-01-21",{"date":59,"type":34},"2025-01-23",{"date":61,"type":34},"2024-03-15",{"date":63,"type":20},"2027-04-01",{"name":65,"class":66},"Anhui Provincial Hospital","OTHER_GOV"]