Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Diffuse Large B-cell Lymphoma

Launched by SHANGHAI CHIA TAI TIANQING PHARMACEUTICAL TECHNOLOGY DEVELOPMENT CO., LTD. · Feb 26, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called TQB2825, which is being given alongside standard chemotherapy for patients with a type of cancer known as diffuse large B-cell lymphoma. The goal is to see how effective this combination is in treating the disease. If you or a loved one has been diagnosed with this type of lymphoma and has received at least one prior treatment, you may be eligible to participate in the trial. Participants should be at least 18 years old, in reasonably good health, and must provide consent to join the study.

If you join the trial, you will receive the TQB2825 injection along with chemotherapy, and your health will be closely monitored throughout the treatment. The study is currently looking for participants, but there are specific eligibility requirements. For example, participants should not have other serious health issues, and they should not have had certain types of cancer treatments recently. This trial aims to explore a potentially new and effective option for patients facing this challenging illness.

Gender

ALL

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.