[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496663":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":47,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":22,"eligibilityCriteria":58,"healthyVolunteers":55,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":22,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":74,"whyStopped":22,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Anhui Provincial Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Administration of Metabolically Armed CD19 CAR-T cells","EXPERIMENTAL","Patients undergo leukapheresis. Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CAR-T cells infusion. A dose of metabolically armed CD19 CAR-T cells will be infused on day 0.",[13],"Drug: Metabolically Armed CD19 CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Metabolically Armed CD19 CAR-T cells","Each subject receive metabolically armed CD19 CAR-T cells by intravenous infusion.",[9],[21],"Meta10-19",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Xingbing Wang, PhD","CONTACT","86-13856007984","wangxingbing@ustc.edu.cn",[30],{"facility":5,"status":31,"city":32,"state":33,"zip":22,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Hefei","Anhui","China","CN",{"type":37,"coordinates":38},"Point",[39,40],117.28083,31.86389,{"lat":40,"lon":39},[43,45],{"name":25,"role":26,"phone":44,"phoneExt":22,"email":28},"+8613856007984",{"name":25,"role":46,"phone":22,"phoneExt":22,"email":22},"PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[50],{"name":51,"class":52},"Leman Biotech Co., Ltd.","INDUSTRY","100496663","early-phase-1-safety-and-efficacy-of-metabolically-armed-cd19-car-t-cells-meta10--19-in-the-treatment-of-rr-b-all-clinical-research-100496663",false,"NCT05747157","Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10- 19) in the Treatment of r\u002Fr B-ALL Clinical Research","Inclusion Criteria:\n\n1. The patient or his\u002Fher guardian voluntarily signed the informed consent；\n2. Patients with relapsed and refractory B-cell Acute Lymphoblastic Leukemia.\n\n   Definition of relapsed or refractory B-ALL (meeting one of the following conditions):\n   1. 2 or more relapses;\n   2. Bone marrow relapsed after allo-HSCT and prepared to infuse Meta10-19 more than 6 months after allo-HSCT ;\n   3. CR not achieved after standardized chemotherapy;\n   4. Philadelphia-chromosome-positive (Ph+) patients who are ineffective or intolerant to first- and second-generation tyrosine kinase inhibitor (TKI) treatments, or who have contraindications to tyrosine kinase inhibitors;\n   5. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is ≥ 5%\n3. CD19 expression was positive by biopsy or flow cytometry (accept the results of this peripheral blood mononuclear cells collection or previous Class A tertiary hospital before this peripheral blood collection);\n4. Expected survival time greater than 12 weeks\n5. The baseline ECOG score was 0 or 1；\n6. Organ function：\n\n   1. Kidney function:\n\n      Serum creatinine ≤1.5 times ULN, or； The glomerular filtration rate (eGFR) estimated by MDRD formula was ≥60m\u002Fmin\u002F1.73m2；\\[eGFR=186×（age）-0.203×SCr-1.154（mg\u002Fdl），for females, the result was ×0.742\\]；\n   2. Liver function： ALT≤5 times ULN, and; Patients with total bilirubin ≤2.0mg\u002Fdl, except those with Gilbert-Meulengracht syndrome. Patients with Gilbert-.Meulengracht syndrome with total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN were included.\n   3. Pulmonary function: ≤CTCAE grade 1 dyspnea and oxygen saturation of blood (SaO2) ≥91% in indoor air environment.\n7. Hemodynamic stability was determined by echocardiography or multichannel radionuclide angiography (MUGA) and LVEF ≥45％;\n8. Patients using the following drugs must meet the following conditions:\n\n   1. Steroid: Therapeutic doses of steroids must be discontinued 2 weeks prior to Meta10-19 infusion. However, physiological replacement doses of steroids are permitted, hydrocortisone or its equivalent \\\u003C 6-12mg\u002Fmm2\u002F day；\n   2. Immunosuppressive agent: Any immunosuppressive drug must be stopped ≥4 weeks before the informed consent is signed;\n   3. Anti-proliferative therapy other than preconditioning chemotherapy is discontinued within 2 weeks prior to Meta10-19 infusion；\n   4. Treatment for CNS disease must be stopped 1 week before Meta10-19 infusion (e.g., intrathecal methotrexate)\n9. The patient has recovered from the toxicity of the previous treatment, that is, the CTCAE toxicity grade is less than 1 (The exception is specific toxicity of grade 2 or less, such as hair loss, which the researchers have determined is not recoverable in a short period of time) is suitable for pretreatment chemotherapy and CAR-T cell therapy;\n10. Women of childbearing age and all male patients must consent to use an effective contraception for at least 12 months after Meta10-19 infusion and until two consecutive PCR tests show no more CAR-T cells in vivo.\n\nExclusion Criteria:\n\n1. Patients with isolated extramedullary relapse;\n2. Patients with confirmed diagnosis of Burkitt's lymphoma\u002F leukemia;\n3. Patients who had received prophylaxis for CNS leukemia within 1 week prior to Meta10-19 infusion;\n4. Patients with present or history of central nervous system diseases such as seizures disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;\n5. Patients with history of allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 6 months prior to Meta10-19 infusion;\n6. Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion ;\n7. Patients who participated in other clinical trials within 30 days prior to enrollment;\n8. Patients with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level \\> 1000 copies\u002Fml) or hepatitis C (HCV RNA positive);\n9. Patients with HIV antibody positive or treponema pallidum antibody positive;\n10. Patients with uncontrolled acute life-threatening bacterial, viral or fungal infections (e.g. positive blood cultures ≤72 hours before Meta10-19 infusion)\n11. Patients with unstable angina pectoris and\u002For myocardial infarction within 6 months prior to enrollment；\n12. Patients with history of other malignancies, but the following conditions can be enrollment:\n\n    1. Adequately treated basal or squamous cell carcinoma (requiring adequate wound healing before signing informed consent);\n    2. Carcinoma in situ (DCIS) of cervical or breast cancer, which has been treated therapeutically, has shown no signs of recurrence for at least 3 years prior to the signing of the informed consent；\n    3. The primary malignancy has been completely resected and in complete remission for ≥5 years。\n13. Women who are pregnant or breastfeeding (pregnancy tests for women of childbearing age are positive);\n14. Patients with active neuroautoimmune or inflammatory conditions (e.g. Guillian-Barre syndrome, amyotrophic lateral sclerosis);\n15. Other conditions that the investigator considered should not be enrolled in this clinical study, such as poor compliance.","ALL","3 Years","70 Years",{"count":63,"type":64},18,"ESTIMATED","INTERVENTIONAL",[67],"EARLY_PHASE1","A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory B-cell Acute Lymphoblastic Leukemia",[70],"B-cell Acute Lymphoblastic Leukemia",[21,72,73],"CAR-T Cells Therapy","r\u002Fr B-ALL","UNKNOWN","2023-11-19",{"date":77,"type":78},"2023-11-21","ACTUAL",{"date":80,"type":78},"2023-02-15",{"date":82,"type":64},"2025-05-15",{"name":5,"class":6},1]