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