Overview
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.
Description
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
Eligibility
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)
