This is an open-label, single-arm, and multicenter phase Ⅱ study designed to evaluate the efficacy and safety of F520 (PD-1) combined with F007(rituximab biosimilar) in patients with Relapsed/Refractory diffuse large B-cell lymphoma. About 62 patients with relapsed/refractory DLBCL plan to be enrolled in about 8 study sites of the study. Primary objective: The purpose is to evaluate the objective response rate of F520 combined with F007 in Relapsed/Refractory diffuse large B-cell lymphoma. Secondary objective: The purpose is to compare the safety of F520 combined with F007 in Relapsed/Refractory diffuse large B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Drug: F007 F007 is an antibody to CD20 molecules. One of the mechanisms of killing tumor cells is through antibody-dependent cell-mediated cytotoxicity (ADCC). Drug: F520 F520 is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2).
1. Objective response rate (ORR)
To evaluate the objective response rate in patients with relapsed or refractory DLBCL.
Time frame: 16 weeks
1. Complete response rate (CRR)
CR was defined as the complete disappearance of all previously detectable disease signs. CRR was percentage of participants with a CR event.
Time frame: 16 weeks
2. Progression-free survival (PFS)
PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause.
Time frame: 2 years
3. Duration of remission (DOR)
The time from the first assessment of complete response or partial response to the first assessment of PD or death.
Time frame: 2 years
4. Time to progression (TTP)
TTP was defined as the time from start of treatment to the date of disease progression.
Time frame: 2 years
5. Overall survival (OS)
OS defined as the time from start of treatment to the date of death due to any cause.
Time frame: 2 years
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