[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525317":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":57,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":22,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":22,"enrollmentInfo":74,"targetDuration":22,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":32,"whyStopped":22,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Zhejiang University","OTHER",[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},"Mingming Zhang","CONTACT","86-13656674208","mingmingzhang@zju.edu.cn",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"The first affiliated hospital of medical college of zhejiang university","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":39,"coordinates":40},"Point",[41,42],120.16142,30.29365,{"lat":42,"lon":41},[45,49,53,55],{"name":46,"role":26,"phone":47,"phoneExt":22,"email":48},"He Huang, MD","86-13605714822","hehuangyu@126.com",{"name":50,"role":26,"phone":51,"phoneExt":22,"email":52},"Yongxian Hu, MD","86-15957162012","huyongxian2000@aliyun.com",{"name":46,"role":54,"phone":22,"phoneExt":22,"email":22},"PRINCIPAL_INVESTIGATOR",{"name":50,"role":56,"phone":22,"phoneExt":22,"email":22},"SUB_INVESTIGATOR",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"SPONSOR_INVESTIGATOR","He Huang","Clinical Professor",[62],{"name":63,"class":64},"Leman Biotech Co., Ltd.","INDUSTRY","100525317","early-phase-1-safety-and-efficacy-of-metabolically-armed-cd19-car-t-cells-meta10-19-in-the-treatment-of-rr-dlbcl-clinical-research-100525317",false,"NCT06120166","Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r\u002Fr DLBCL Clinical Research","Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10- 19) in the Treatment of r\u002Fr DLBCL Clinical Research","Inclusion Criteria:\n\n* The patient or his\u002Fher guardian voluntarily signed the informed consent\n* Adult Patients clinical diagnosis of relapsed and refractory diffuse large B-cell lymphoma (Primary mediastinal large B-cell lymphoma and transformed follicular lymphoma are included)\n\nDefinition of refractory:\n\n1. No response to the last treatment, including:\n\n   The best response to the last treatment was PD, or ; The best response to the last treatment was SD and the duration was not more than 6 months after the last dose.\n2. Not suitable for autologous hematopoietic stem cell transplantation (ASCT), or ASCT refractory, including:\n\nDisease progression or recurrence within 12 months or less (recurrence must be confirmed by biopsy) after ASCT treatment, or; Patients accept remedial treatment after ASCT must have no response or relapse after the last treatment\n\n* Patients who had previously received ≥2 lines therapy including at least:\n\n  1. A chemotherapy regimen containing anthracyclines\n  2. For patients with transformed DLBCL from follicular lymphoma, they must have previously received chemotherapy for follicular lymphoma and have refractory disease after transformation to DLBCL.\n* Patients with double-strike and triple-strike lymphoma who do not respond to second-line treatment, where double-strike\u002Ftriple-strike is defined as:\n\nDetection of lymphoma cells with C-MYC gene translocation accompanied by BCL-2 gene translocation or\u002Fand BCL-6 gene translocation by chromosome or FISH technology.\n\n* CD19 expression was positive by immunohistochemistry or flow cytometry (accept the results of this peripheral blood mononuclear cells or previous report from a Class A tertiary hospital before peripheral blood collection)\n* At least one measurable lesion at baseline, according to the initial assessment, staging and Response Assessment recommendations for Hodgkin's and non-Hodgkin's lymphoma (2014 edition)\n* Expected survival time greater than 12 weeks\n* The baseline ECOG score was 0 or 1\n* Organ function:\n\n  1. Kidney function is defined as:\n\n     Serum creatinine ≤1.5 times ULN, or; The glomerular filtration rate (eGFR) estimated by MDRD formula was ≥60m\u002F min\u002F1.73m2; \\[eGFR=186×(age)-0.203×SCr- 1. 154(mg\u002Fdl), for females, the result was ×0.742\\]\n  2. Liver function is defined as:\n\n     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.\n* Hemodynamic stability was determined by echocardiography or multichannel radionuclide angiography (MUGA) and LVEF ≥45%\n* 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 \\\u003C6-12mg\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 in addition to preconditioning chemotherapy 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)\n* 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\n* Women of childbearing age and all male patients must consent to use a 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\n* 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\n* Patients with history of allogeneic hematopoietic stem cell transplantation\n* Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion\n* Patients who participated in other clinical trials within 30 days prior to enrollment\n* 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)\n* Patients with HIV antibody positive or treponema pallidum antibody positive\n* Patients with uncontrolled acute life-threatening bacterial, viral or fungal infections (e.g. positive blood cultures ≤72 hours before Meta10-19infusion)\n* Patients with unstable angina pectoris and\u002For myocardial infarction within 6 months prior to enrollment\n* 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\n* Women who are pregnant or breastfeeding (pregnancy tests for women of childbearing age are positive)\n* Patients with active neuroautoimmune or inflammatory conditions (e.g. Guillian-Barre syndrome, amyotrophic lateral sclerosis);\n* Other conditions that the investigator considered should not be enrolled in this clinical study, such as poor compliance.","ALL","18 Years",{"count":75,"type":76},18,"ESTIMATED","INTERVENTIONAL",[79],"EARLY_PHASE1","A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory Diffuse Large B-Cell Lymphoma",[82],"Diffuse Large B-cell Lymphoma",[21,84,85],"CAR-T Cells Therapy","r\u002Fr DLBCL","2025-09-15",{"date":88,"type":89},"2025-09-19","ACTUAL",{"date":91,"type":89},"2023-11-16",{"date":93,"type":76},"2026-04-05",{"name":59,"class":6},1]