Phase II Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma
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.
⁃ 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;