[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621257":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":42,"collaborators":20,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":20,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":20,"enrollmentInfo":53,"targetDuration":20,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Jiangsu Topcel-KH Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Biological: Anti-PD1 armored CD19 CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Anti-PD1 armored CD19 CAR-T cells","Anti-PD1 armored CD19 CAR-T cells, single intravenous infusion",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Xiao Ma","CONTACT","0512-83837999","colleenld2020@hotmail.com",[28],{"facility":29,"status":30,"city":31,"state":20,"zip":20,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Suzhou Hongci Hematology Hospital","RECRUITING","Suzhou","China","CN",{"type":35,"coordinates":36},"Point",[37,38],120.59538,31.30408,{"lat":38,"lon":37},[41],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":43,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100621257","phase-1-safety-and-efficacy-study-of-anti-pd1-armored-cd19-car-t-cells-in-adult-subjects-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-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":54,"type":55},30,"ESTIMATED","INTERVENTIONAL",[58],"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.",[61],"Diffuse Large B Cell Lymphoma","2026-01-26",{"date":64,"type":65},"2026-01-28","ACTUAL",{"date":67,"type":55},"2026-01",{"date":69,"type":55},"2029-01",{"name":5,"class":6},1]