Phase
Condition
Lymphoma
Treatment
TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The subjects voluntarily participate in this study, sign the informed consent form,and have good compliance;
Age ≥18 years (calculated from the date of informed consent);
Eastern Cooperative Oncology Group (ECOG) score 0 ~ 2 points;
Expected survival greater than 12 weeks;
Histological or cytological diagnosis of diffuse large B-cell lymphoma in accordancewith the World Health Organization (WHO) diagnostic criteria in 2022;
Pathological diagnosis results containing CD20 positive expression and Mycrearrangement negative after anti-CD20 treatment must be provided;
Subjects with relapsed or refractory diffuse large B-cell lymphoma who have receivedat least 1 line of systemic therapy;
Not suitable for hematopoietic stem cell transplantation;
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 > 10mm according to CT cross-sectional images; Positron emission tomography -computerized tomography (PET-CT) scan shows PET positive;
Laboratory tests meet specific criteria;
Adopt effective contraceptive measures;
Exclusion
Exclusion Criteria:
Subjects who had or currently had other malignant tumors within 5 years prior to thefirst dose;
Previous or current involvement or suspected involvement of the central nervoussystem by lymphoma;
Failure to recover from adverse reactions to Common Terminology Criteria for AdverseEvents version 5.0 (CTCAEv5.0) criteria ≤ grade 1 from previous treatment;
History of previous anti-tumor treatment:
previous use of other antibody drugs targeting CD3 and CD20 at the same time;
received Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) therapy, orother immune cell therapy, or autologous hematopoietic stem celltransplantation (auto-HSCT) within 3 months before the first dose;
previous treatment with R-GemOx or GemOx;
received chemotherapy, immunotherapy, monoclonal antibody therapy 4 timesbefore the first dose, 2 times received radiotherapy or small molecule targeteddrugs, or subjects who are still within 5 half-lives of the drug, the washoutperiod is calculated from the end time of treatment;
received treatment with Chinese patent medicines with clear anti-tumorindications in the package insert of National Medical Products Administration (NMPA)-approved drugs 2 times before the first dose;
Subjects who have undergone major surgical treatment, significant traumatic injury,or expected major surgery during the study treatment period within 4 weeks prior tothe first use of medication, or have long-term untreated wounds or fractures;
Subjects who experience any bleeding or bleeding events ≥ Common TerminologyCriteria Adverse Event (CTC AE) grade 3 within 4 weeks prior to the firstadministration;
Hyperactive/venous thrombotic events within 6 months prior to first dose,Such ascerebrovascular accident (including transient ischemic attack), deep venousthrombosis and pulmonary embolism or any other history of severe thromboembolism;
Clinically significant uncontrolled pleural effusion, ascites and more than moderatepericardial effusion requiring repeated drainage;
Decompensated cirrhosis (Child-Pugh class B or C liver function) and activehepatitis;
Pulmonary disease, including any of the following: 1) with or without currentpneumonitis requiring corticosteroid therapy; 2) with or suspected chronicobstructive pulmonary disease (COPD), and forced expiratory volume in 1 second (FEV1) < 60% (predicted);
Brain or mental disorders;
Have major cardiovascular disease;
Active or uncontrolled infection (≥ CTCAE grade 2 infection), including bacterial,fungal or viral infections including but not limited to active pneumonia, syphilisand tuberculosis.
Unexplained fever > 38.5℃ during screening or before the first dose;
Renal failure requiring hemodialysis or peritoneal dialysis, previous history ofnephrotic syndrome;
History of immunodeficiency, including HIV-positive or other acquired, congenitalimmunodeficiency diseases;
Have or have had prior autoimmune disease requiring treatment.
Prepare to undergo or have previously received organ transplantation, or have asignificant host transplant response, or have previously received allogeneichematopoietic stem cell transplantation; 19、Need to receive systemicimmunosuppressive therapy;
Known or suspected history of hemophagocytic syndrome (HLH);
Known hypersensitivity to excipient components of the study drug.
Subjects who participated in other anti-tumor clinical trials within 4 or 5half-lives before the first dose.
Any condition that, in the judgment of the investigator, would jeopardize the safetyof the subject or prevent the subject from completing the study.
Study Design
Connect with a study center
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui 241001
ChinaSite Not Available
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian 361003
ChinaSite Not Available
Gansu Provincial Cancer Hospital
Lanzhou, Gansu 730050
ChinaSite Not Available
Affiliated Cancer Hospital and insititute Guangzhou Medical University
Guangzhou, Guangdong 510095
ChinaSite Not Available
Guangxi Medical University Cancer Hospital
Nanning, Guangxi 530021
ChinaSite Not Available
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei 050011
ChinaSite Not Available
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang 150081
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan 450008
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450052
ChinaSite Not Available
Hubei Cancer Hospital (HBCH)
Wuhan, Hubei 430079
ChinaSite Not Available
Zhongnan Hospital of Wuhan University
Wuhan, Hubei 434000
ChinaSite Not Available
Hunan Cancer Hospital
Changsha, Hunan 410000
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha, Hunan 410011
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing, Jiangsu 210000
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaSite Not Available
Jiangxi Cancer Hospital
Nanchang, Jiangxi 330029
ChinaSite Not Available
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning 116000
ChinaActive - Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi 710061
ChinaSite Not Available
Shandong cancer hospital
Jinan, Shandong 250117
ChinaSite Not Available
Weihai Central Hospital
Weihai, Shandong 264499
ChinaSite Not Available
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi 030000
ChinaSite Not Available
Sichuan Provincal People's Hospital
Chengdu, Sichuan 610072
ChinaSite Not Available
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan 646000
ChinaSite Not Available
THE First Affiliated Hospital ZheJiang University School of Medicine
Hangzhou, Zhejiang 310000
ChinaSite Not Available
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