[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diffuse-large-cell-b-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diffuse-large-cell-b-lymphoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100581756","phase-2-clinical-trial-of-tqb2825-injection-combined-with-chemotherapy-in-subjects-with-diffuse-large-b-cell-lymphoma-100581756",false,"NCT06854445","Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Diffuse Large B-cell Lymphoma","Phase II Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* The subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;\n* Age ≥18 years (calculated from the date of informed consent);\n* Eastern Cooperative Oncology Group (ECOG) score 0 \\~ 2 points;\n* Expected survival greater than 12 weeks;\n* Histological or cytological diagnosis of diffuse large B-cell lymphoma in accordance with the World Health Organization (WHO) diagnostic criteria in 2022;\n* Pathological diagnosis results containing CD20 positive expression and Myc rearrangement negative after anti-CD20 treatment must be provided;\n* Subjects with relapsed or refractory diffuse large B-cell lymphoma who have received at least 1 line of systemic therapy;\n* Not suitable for hematopoietic stem cell transplantation;\n* According to the Lugano criteria in 2014, there is at least one measurable lesion, that is, the long diameter of lymph node lesions \\> 15 mm or extranodal lesions \\> 10 mm according to CT cross-sectional images; Positron emission tomography - computerized tomography (PET-CT) scan shows PET positive;\n* Laboratory tests meet specific criteria;\n* Adopt effective contraceptive measures;\n\nExclusion Criteria:\n\n* Subjects who had or currently had other malignant tumors within 5 years prior to the first dose;\n* Previous or current involvement or suspected involvement of the central nervous system by lymphoma;\n* Failure to recover from adverse reactions to Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5.0) criteria ≤ grade 1 from previous treatment;\n* History of previous anti-tumor treatment:\n\n  1. previous use of other antibody drugs targeting CD3 and CD20 at the same time;\n  2. received Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) therapy, or other immune cell therapy, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months before the first dose;\n  3. previous treatment with R-GemOx or GemOx;\n  4. received chemotherapy, immunotherapy, monoclonal antibody therapy 4 times before the first dose, 2 times received radiotherapy or small molecule targeted drugs, or subjects who are still within 5 half-lives of the drug, the washout period is calculated from the end time of treatment;\n  5. received treatment with Chinese patent medicines with clear anti-tumor indications in the package insert of National Medical Products Administration (NMPA)-approved drugs 2 times before the first dose;\n* Subjects who have undergone major surgical treatment, significant traumatic injury, or expected major surgery during the study treatment period within 4 weeks prior to the first use of medication, or have long-term untreated wounds or fractures;\n* Subjects who experience any bleeding or bleeding events ≥ Common Terminology Criteria Adverse Event (CTC AE) grade 3 within 4 weeks prior to the first administration;\n* Hyperactive\u002Fvenous thrombotic events within 6 months prior to first dose,Such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism or any other history of severe thromboembolism;\n* Clinically significant uncontrolled pleural effusion, ascites and more than moderate pericardial effusion requiring repeated drainage;\n* Decompensated cirrhosis (Child-Pugh class B or C liver function) and active hepatitis;\n* Pulmonary disease, including any of the following: 1) with or without current pneumonitis requiring corticosteroid therapy; 2) with or suspected chronic obstructive pulmonary disease (COPD), and forced expiratory volume in 1 second (FEV1) \\\u003C 60% (predicted);\n* Brain or mental disorders;\n* Have major cardiovascular disease;\n* Active or uncontrolled infection (≥ CTCAE grade 2 infection), including bacterial, fungal or viral infections including but not limited to active pneumonia, syphilis and tuberculosis.\n* Unexplained fever \\> 38.5℃ during screening or before the first dose;\n* Renal failure requiring hemodialysis or peritoneal dialysis, previous history of nephrotic syndrome;\n* History of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency diseases;\n* Have or have had prior autoimmune disease requiring treatment.\n* Prepare to undergo or have previously received organ transplantation, or have a significant host transplant response, or have previously received allogeneic hematopoietic stem cell transplantation; 19、Need to receive systemic immunosuppressive therapy;\n* Known or suspected history of hemophagocytic syndrome (HLH);\n* Known hypersensitivity to excipient components of the study drug.\n* Subjects who participated in other anti-tumor clinical trials within 4 or 5 half-lives before the first dose.\n* Any condition that, in the judgment of the investigator, would jeopardize the safety of the subject or prevent the subject from completing the study.","ALL","18 Years",{"count":19,"type":20},55,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to assess the preliminary efficacy of TQB2825 in combination with chemotherapy in subjects with diffuse large B-cell lymphoma.",[26],"Diffuse Large Cell B-lymphoma","RECRUITING","2025-03-19",{"date":30,"type":31},"2025-03-24","ACTUAL",{"date":33,"type":31},"2025-03-12",{"date":35,"type":20},"2028-02",{"name":37,"class":38},"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.","INDUSTRY",24]