NCT07808827RecruitingPhase 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
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 282 (estimated)
- First submitted
- 2 Sept 2026
- Start date
- 8 Oct 2026
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT07808827
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 282
- From 8 Oct 2026 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously received CD20-CD3 bispecific antibody treatment；
- Previous allogeneic hematopoietic stem cell transplantation；
- Previous solid organ transplantation
Other illness
- A history of severe allergy to monoclonal antibody therapy (or recombinant antibody-related fusion protein)；
- 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)
Other
- There is pleural effusion, peritoneal effusion or pericardial effusion that requires treatment (such as puncture or drainage)
Who the study is looking for
- 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；
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.