A Randomized, Open-Label, Multicenter Phase III Clinical Study of JS203 Plus Chemotherapy Versus Rituximab Plus Chemotherapy in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Randomized, Open-Label, Multicenter Phase III Clinical Study of JS203 Plus Chemotherapy Versus Rituximab Plus Chemotherapy in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (JS203-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.

A Randomized Open-Label Multicenter Phase III Clinical Trial Comparing JS203 Combined With gemcitabine plus oxaliplatin (JS203-GemOx) Versus rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Inclusion Criteria:

• Patients must meet all of the following inclusion criteria to be enrolled:
• Age range: 18 to 75 years old (inclusive), both male and female are acceptable
• ECOG: 0-1；
• One of the confirmed histologies below with CD20-positivity:

DLBCL, not otherwise specified (NOS), including de novo or histologically transformed from follicular lymphoma (FL)/Marginal Zone Lymphoma(MZL) "Double-hit" or "triple-hit" DLBCL , including de novo or histologically transformed from FL/MZL FL Grade 3B T-cell/histiocyte-rich large B-cell lymphoma

• At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment；
• Acceptable organ function at screening；

Exclusion Criteria:

• A history of severe allergy to monoclonal antibody therapy (or recombinant antibody-related fusion protein)；
• Previously received CD20-CD3 bispecific antibody treatment；
• Previous allogeneic hematopoietic stem cell transplantation；
• Previous solid organ transplantation
• History of autoimmune diseases
• Patients with a history of macrophage activation syndrome (MAS)/ hemophagocytic lymphohistiocytosis (HLH)
• Patients with a history of progressive multifocal leukoencephalopathy (PML)
• A known or suspected history of CNS lymphoma (including primary or secondary)
• There is pleural effusion, peritoneal effusion or pericardial effusion that requires treatment (such as puncture or drainage)