Clinical trial · Interventional
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
NCT07808827CI-TRIAL-00126188not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JS203 in combination with gemcitabine and oxaliplatin | Combination Product | — | UNRESOLVED |
| Rituximab in combination with gemcitabine and oxaliplatin | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- JS203+Gemox
- interventionNames
- Combination Product: JS203 in combination with gemcitabine and oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- Rituximab+Gemox
- interventionNames
- Combination Product: Rituximab in combination with gemcitabine and oxaliplatin
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- up to approximately 24 months
- description
- Overall survival (OS) evaluated based on 2014 Lugano criteria
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.