[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621257":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":38,"studyPopulation":31,"armGroups":39,"interventions":46,"overallOfficials":31,"centralContacts":52,"locations":58,"responsibleParty":73,"collaborators":31,"id":75,"slug":31,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":31,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":31,"enrollmentInfo":83,"targetDuration":31,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":31,"overallStatus":61,"whyStopped":31,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Jiangsu Topcel-KH Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":31},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of dose-limiting toxicity (DLT)","Dose-limiting toxicity for each subject","1 month after injection",{"measure":14,"description":15,"timeFrame":16},"AE\u002FSAE","Incidence and severity of adverse events (AE), and serious adverse event (SAE)","1 month, 3 months, 6 months, 12 months after injection",[18,22,25,28],{"measure":19,"description":20,"timeFrame":21},"Objective response rate (ORR)","Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients","1 month, 3 months, 6 months, 9 months, 12 months after injection",{"measure":23,"description":24,"timeFrame":21},"Overall survival (OS)","Defined as the time from the date of first infusion to death due to any cause",{"measure":26,"description":27,"timeFrame":21},"Duration of response (DOR)","The time from the date of first response (PR or better) to the date of disease progression after infusion",{"measure":29,"description":30,"timeFrame":21},"Progression-free survival (PFS)","The time from first infusion to the date of progression or death",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"NA","SINGLE_GROUP","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":31},"NONE","This is a prospective, open-label, single-arm clinical study to evaluate the safety, tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory diffuse large B-cell lymphoma (r\u002Fr DLBCL).The study plans to explore across three dose levels (1.00 × 10\\^6, 3.00 × 10\\^6, 9.00 × 10\\^6 CAR+ T cells\u002Fkg), and 6.00×10\\^8 CAR+T cells as maximum dose, aiming to evaluate the safety, tolerability of anti-PD1 armored CD19 CAR-T Cells in r\u002Fr DLBCL, explore Maximum Tolerated Dose (MTD) and determine the recommended dose for Phase II. Besides, efficacy, pharmacokinetics and persistence profile of CAR-T cells are also study objectives.",[40],{"label":41,"type":42,"description":43,"interventionNames":44},"Anti-PD1 armored CD19 CAR-T cells treatment arm","EXPERIMENTAL","Subjects will be administrated with Anti-PD1 armored CD19 CAR-T cells after lymphocyte depletion by fludarabine and cyclophosphamide.",[45],"Biological: Anti-PD1 armored CD19 CAR-T cells",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":31},"BIOLOGICAL","Anti-PD1 armored CD19 CAR-T cells","Anti-PD1 armored CD19 CAR-T cells, single intravenous infusion",[41],[53],{"name":54,"role":55,"phone":56,"phoneExt":31,"email":57},"Xiao Ma","CONTACT","0512-83837999","colleenld2020@hotmail.com",[59],{"facility":60,"status":61,"city":62,"state":31,"zip":31,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Suzhou Hongci Hematology Hospital","RECRUITING","Suzhou","China","CN",{"type":66,"coordinates":67},"Point",[68,69],120.59538,31.30408,{"lat":69,"lon":68},[72],{"name":54,"role":55,"phone":56,"phoneExt":31,"email":57},{"type":74,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100621257",false,"NCT07368270","Safety and Efficacy Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma","A Prospective, Open-label and Single-arm Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* 1\\. Subjects voluntarily participate in clinical research and sign informed consent.\n* 2\\. Adult subjects (age ≥18 ) with relapsed or refractory diffuse large B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months; b) achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; c) not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation).\n* 3\\. Expected survival ≥ 3 months.\n* 4\\. At least one measurable lesion as per revised IWG response criteria for malignant lymphom (2014 Lugano criteria).\n* 5\\. CD19 positive expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry.\n* 6\\. ECOG score ≤ 2.\n* 7\\. Subjects with adequate organ functions prior to enrollment, meet the following laboratory values:\n* Renal function: serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m².\n* Hepatic function: Serum alanine aminotransferase (ALT) ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg\u002FdL, except in subjects with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN, subjects with Gilbert-Meulengracht syndrome are included.\n* Pulmonary reserve: ≤ Grade 1 dyspnea and oxygen saturation \\>95% on room air.\n* 8\\. Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA).\n* 9\\. Adequate bone-marrow reserve without blood transfusion as defined by:\n* Absolute neutrophil count (ANC) ≥ 1 x 10\\^9\u002FL.\n* Absolute lymphocyte count (ALC) ≥ 0.1 x 10\\^9\u002FL.\n* Platelets ≥ 50 x 10\\^9\u002FL.\n* Hemoglobin \\>80g\u002FL.\n* 10\\. In the investigator's judgment, subjects' general condition and all biochemical values are either normal or sufficiently compensated to receive lymphodepletion and CAR-T cell therapy.\n\nExclusion Criteria:\n\n* 1\\. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.\n* 2\\. Infectious disease(HIV, Active Tuberculosis ect.).\n* 3\\. Active infection: hepatitis B, hepatitis C.\n* 4\\. Abnormal vital signs or refuse to receive examination.\n* 5\\. Subjects with psychiatric or psychological disorders are unable to complete treatment or efficacy assessment.\n* 6.History of severe hypersensitivity or known hypersensitivity to IL-2.\n* 7\\. Systemic or local severe infection requiring antimicrobial therapy.\n* 8\\. Significant dysfunction of vital organs (heart, lung, brain, kidney, etc.), or in the investigator's judgment, subjects are unable to be enrolled with any other condition.","ALL","18 Years",{"count":84,"type":85},30,"ESTIMATED","INTERVENTIONAL",[88],"PHASE1","The purpose of this study is to investigate the safety and tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory diffuse large B-cell lymphoma.",[91],"Diffuse Large B Cell Lymphoma","2026-01-26",{"date":94,"type":95},"2026-01-28","ACTUAL",{"date":97,"type":85},"2026-01",{"date":99,"type":85},"2029-01",{"name":5,"class":6},1]