drugset / Trial / NCT05178836

A Phase II Study to Evaluate the Efficacy and Safety of F520 Combined With F007 in Patients With RR DLBCL

NCT05178836

Phase 2 Unknown 62 enrolled Shandong New Time Pharmaceutical Co., LTD
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2022-01-01
Primary completion
2023-12-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject F007 Unknown 375 mg/m2 Intravenous
Subject F520 Monoclonal antibody 200 mg Intravenous