clinical trial of tqb2825 injection combined with chemotherapy in subjects with diffuse large b-cell lymphoma

Conditions: Diffuse Large Cell B-lymphoma

Summary: 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.


Eligibility criteria:
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 accordance with the world health organization (who) diagnostic criteria in 2022; * pathological diagnosis results containing cd20 positive expression and myc rearrangement negative after anti-cd20 treatment must be provided; * subjects with relapsed or refractory diffuse large b-cell lymphoma who have received at 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 \> 10 mm 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 criteria: * subjects who had or currently had other malignant tumors within 5 years prior to the first dose; * previous or current involvement or suspected involvement of the central nervous system by lymphoma; * failure to recover from adverse reactions to common terminology criteria for adverse events version 5.0 (ctcaev5.0) criteria ≤ grade 1 from previous treatment; * history of previous anti-tumor treatment: 1. previous use of other antibody drugs targeting cd3 and cd20 at the same time; 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; 3. previous treatment with r-gemox or gemox; 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; 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; * 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; * 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; * hyperactive/venous 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; * clinically significant uncontrolled pleural effusion, ascites and more than moderate pericardial effusion requiring repeated drainage; * decompensated cirrhosis (child-pugh class b or c liver function) and active hepatitis; * 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) \< 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, syphilis and tuberculosis. * unexplained fever \> 38.5℃ during screening or before the first dose; * renal failure requiring hemodialysis or peritoneal dialysis, previous history of nephrotic syndrome; * history of immunodeficiency, including hiv-positive or other acquired, congenital immunodeficiency diseases; * have or have had prior autoimmune disease requiring treatment. * 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; * 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 5 half-lives before the first dose. * any condition that, in the judgment of the investigator, would jeopardize the safety of the subject or prevent the subject from completing the study.