[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525317":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":33,"studyPopulation":26,"armGroups":34,"interventions":41,"overallOfficials":26,"centralContacts":49,"locations":55,"responsibleParty":83,"collaborators":87,"id":91,"slug":26,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":26,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":26,"enrollmentInfo":99,"targetDuration":26,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":58,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Zhejiang University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"MTD","Determine the Maximal Tolerable Dose(MTD)","MTD will be determined based on DLTs observed during the first 28 days of study treatment.",{"measure":14,"description":15,"timeFrame":16},"Objective response rate (ORR)","Measure Tumor response rate (including CR and PR)","Within 3 months following infusion of Meta10-19",[18,22],{"measure":19,"description":20,"timeFrame":21},"Concentration of CAR-T cells","Concentration of CAR-T cells measured by Flow cytometry after CAR-T infusion","Up to 12 months after CAR-T treatment",{"measure":23,"description":24,"timeFrame":25},"Pharmacodynamics of CAR-T cells","Concentration levels of CAR-T related serum cytokines such as CRP, IL-6, INF-γ at each time point","Up to 28 days after infusion",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SEQUENTIAL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE","This is a single arm, open-label study. This study is indicated for relapsed or refractory CD19+ Diffuse Large B-Cell Lymphoma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products.\n\n1. Main research objectives:\n\n   To evaluate the safety and efficacy of metabolically armed CD19 CAR-T Cells in the treatment of r\u002Fr DLBCL.\n2. Secondary research objectives:\n\n   1. To evaluate the pharmacokinetic (PK) and pharmacodynamics(PD) characteristics of metabolically armed CD19 CAR-T Cells after infusion.\n   2. To evaluate tumor remission after infusion of metabolically armed CD19 CAR-T Cells.",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"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.",[40],"Drug: Metabolically Armed CD19 CAR-T cells",[42],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"DRUG","Metabolically Armed CD19 CAR-T cells","Each subject receive metabolically armed CD19 CAR-T cells by intravenous infusion",[36],[48],"Meta10-19",[50],{"name":51,"role":52,"phone":53,"phoneExt":26,"email":54},"Mingming Zhang","CONTACT","86-13656674208","mingmingzhang@zju.edu.cn",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"The first affiliated hospital of medical college of zhejiang university","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":65,"coordinates":66},"Point",[67,68],120.16142,30.29365,{"lat":68,"lon":67},[71,75,79,81],{"name":72,"role":52,"phone":73,"phoneExt":26,"email":74},"He Huang, MD","86-13605714822","hehuangyu@126.com",{"name":76,"role":52,"phone":77,"phoneExt":26,"email":78},"Yongxian Hu, MD","86-15957162012","huyongxian2000@aliyun.com",{"name":72,"role":80,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":76,"role":82,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","He Huang","Clinical Professor",[88],{"name":89,"class":90},"Leman Biotech Co., Ltd.","INDUSTRY","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":100,"type":101},18,"ESTIMATED","INTERVENTIONAL",[104],"EARLY_PHASE1","A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and\u002For Refractory Diffuse Large B-Cell Lymphoma",[107],"Diffuse Large B-cell Lymphoma",[48,109,110],"CAR-T Cells Therapy","r\u002Fr DLBCL","2025-09-15",{"date":113,"type":114},"2025-09-19","ACTUAL",{"date":116,"type":114},"2023-11-16",{"date":118,"type":101},"2026-04-05",{"name":85,"class":6},1]