[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581756":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":381,"collaborators":19,"id":383,"slug":384,"hasResults":385,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":19,"eligibilityCriteria":389,"healthyVolunteers":385,"sex":390,"minAge":391,"maxAge":19,"enrollmentInfo":392,"targetDuration":19,"studyType":395,"phases":396,"briefSummary":398,"conditions":399,"keywords":19,"overallStatus":264,"whyStopped":19,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":411},{"fullName":5,"class":6},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection","EXPERIMENTAL","The subject received TQB2825 injection, gemcitabine hydrochloride for injection, and oxaliplatin for injection.",[13],"Drug: TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Drug: TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection;\n\nOther Name:\n\nGemcitabine Hydrochloride for Injection, Zefei; Oxaliplatin for Injection, Aihen\n\nTQB2825 injection is Cluster of Differentiation 3 (CD3) and and Cluster of Differentiation 20 (CD20) bispecific antibody; Gemcitabine hydrochloride for injection is a cell cycle-specific antimetabolite; Oxaliplatin for Injection is a platinum chemotherapy drug.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Qingqing Cai, Doctor","CONTACT","13798101121","caiqq@sysucc.org.cn",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Rong Tao, 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of Wuhan University","434000",{"type":40,"coordinates":185},[173,174],{"lat":174,"lon":173},[188],{"name":189,"role":23,"phone":190,"phoneExt":19,"email":191},"Yu Liu, Doctor","13667148436","1243869986@qq.com",{"facility":193,"status":33,"city":194,"state":195,"zip":196,"country":37,"countryCode":38,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Hunan Cancer Hospital","Changsha","Hunan","410000",{"type":40,"coordinates":198},[199,200],112.97087,28.19874,{"lat":200,"lon":199},[203],{"name":204,"role":23,"phone":205,"phoneExt":19,"email":206},"Yajun Li, Doctor","19918803330","19918803330@163.com",{"facility":208,"status":33,"city":194,"state":195,"zip":209,"country":37,"countryCode":38,"cosmosGeoPoint":210,"geoPoint":212,"contacts":213},"The Second Xiangya Hospital of Central South University","410011",{"type":40,"coordinates":211},[199,200],{"lat":200,"lon":199},[214],{"name":215,"role":23,"phone":216,"phoneExt":19,"email":217},"Jinan Ma, 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Doctor","13642138692","zengjunli@163.com",{"facility":309,"status":33,"city":310,"state":296,"zip":311,"country":37,"countryCode":38,"cosmosGeoPoint":312,"geoPoint":316,"contacts":317},"Weihai Central Hospital","Weihai","264499",{"type":40,"coordinates":313},[314,315],122.11356,37.50914,{"lat":315,"lon":314},[318],{"name":319,"role":23,"phone":320,"phoneExt":19,"email":321},"Xiangjun Sun, Master","13561886329","943221801@qq.com",{"facility":323,"status":33,"city":324,"state":325,"zip":326,"country":37,"countryCode":38,"cosmosGeoPoint":327,"geoPoint":331,"contacts":332},"Shanxi Provincial Cancer Hospital","Taiyuan","Shanxi","030000",{"type":40,"coordinates":328},[329,330],112.56028,37.86944,{"lat":330,"lon":329},[333],{"name":334,"role":23,"phone":335,"phoneExt":19,"email":336},"Liping Su, Doctor","13835158122","slpsy2022@163.com",{"facility":338,"status":33,"city":339,"state":340,"zip":341,"country":37,"countryCode":38,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"Sichuan Provincal People's Hospital","Chengdu","Sichuan","610072",{"type":40,"coordinates":343},[344,345],104.06667,30.66667,{"lat":345,"lon":344},[348],{"name":349,"role":23,"phone":350,"phoneExt":19,"email":351},"Xiaobing Huang, Doctor","18981838236","hxb_trial@163.com",{"facility":353,"status":33,"city":354,"state":340,"zip":355,"country":37,"countryCode":38,"cosmosGeoPoint":356,"geoPoint":360,"contacts":361},"The Affiliated Hospital of Southwest Medical University","Luzhou","646000",{"type":40,"coordinates":357},[358,359],105.42575,28.8903,{"lat":359,"lon":358},[362],{"name":363,"role":23,"phone":364,"phoneExt":19,"email":365},"Xiaoming Li, Master","13700986866","LXM6358@21.com.cn",{"facility":367,"status":33,"city":368,"state":369,"zip":370,"country":37,"countryCode":38,"cosmosGeoPoint":371,"geoPoint":375,"contacts":376},"THE First Affiliated Hospital ZheJiang University School of Medicine","Hangzhou","Zhejiang","310000",{"type":40,"coordinates":372},[373,374],120.16142,30.29365,{"lat":374,"lon":373},[377],{"name":378,"role":23,"phone":379,"phoneExt":19,"email":380},"Hongyan Tong, Doctor","13958122357","hongyantong@aliyun.com",{"type":382,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","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":393,"type":394},55,"ESTIMATED","INTERVENTIONAL",[397],"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.",[400],"Diffuse Large Cell B-lymphoma","2025-03-19",{"date":403,"type":404},"2025-03-24","ACTUAL",{"date":406,"type":404},"2025-03-12",{"date":408,"type":394},"2028-02",{"name":410,"class":6},"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.",24]