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;
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;
previous use of other antibody drugs targeting CD3 and CD20 at the same time;
Single group
TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection
DrugDrug: TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection; Other Name: Gemcitabine Hydrochloride for Injection, Zefei; Oxaliplatin for Injection, Aihen TQB2825 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.
Complete response rate (CR rate)
Percentage of subjects with complete (CR) per 2014 Lugano criteria.
Overall response rate (ORR)
Percentage of subjects with complete (CR) or partial response (PR) according to 2014 Lugano Criteria.
Progression-free survival (PFS)
Time from randomization or first dose to disease progression or death from any cause, whichever occurs first, as determined by the 2014 Lugano Criteria.
Duration of Response (DOR)
The time from first achievement of response, to disease progression or death from any cause, whichever comes first, was determined according to the 2014 Lugano criteria.
Time to Response (TTR)
Time from randomization or first dose of trial drug to the first evaluation of PR or CR, whichever occurs first.
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