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Clinical Trials in China / NCT07808827
Starting soon Phase 3

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

NCT07808827 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Phase
Phase 3
Started
2026-09-24
Last updated
2026-09-09

Condition(s) studied

Diffuse Large B-Cell Lymphoma

Investigational drug(s) / intervention(s)

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)

Trial sites (1)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing Beijing Municipality

More Shanghai Junshi Bioscience Co., Ltd. trials in China

Other trials for the same condition

Official registry record

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.

View NCT07808827 on ClinicalTrials.gov ↗ ← All trials in China