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Recruiting NCT07808827

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

Conditions: Diffuse Large B-Cell Lymphoma

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 282
Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Location: Beijing Cancer Hospital Beijing Beijing Municipality

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 Criteria

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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07808827). StuddyBuddy aggregates publicly available trial information.