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
JS203 in combination with gemcitabine and oxaliplatinRituximab in combination with gemcitabine and oxaliplatin
JS203 in combination with gemcitabine and oxaliplatin: gemcitabine and oxaliplatin 8 cycles (Q3W) and JS203 (21 days/cycle) Cycle 1 QW,Cycle 2 and therafter Q3W for up to 1 year
Rituximab in combination with gemcitabine and oxaliplatin: Rituximab and gemcitabine and oxaliplatin 8 cycles (Q3W)
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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)
Primary outcome measure(s)
Overall survival (OS) — up to approximately 24 months Overall survival (OS) evaluated based on 2014 Lugano criteria
Trial sites (1)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
Beijing Municipality
More Shanghai Junshi Bioscience Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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