Diffuse Large B-Cell LymphomaPhase 3NCT07808827
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
A Phase 3 study testing JS203 in combination with gemcitabine and oxaliplatin and Rituximab in combination with gemcitabine and oxaliplatin in people with Diffuse Large B-Cell Lymphoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- JS203 in combination with gemcitabine and oxaliplatin and Rituximab in combination with gemcitabine and oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2026to 28 Feb 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yuqin Song, Ph.D, 010-88196118, SongYQ_VIP@163.com
Yuqin Song, Ph.D
About this study
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.
Read the detailed description
A Randomized Open-Label Multicenter Phase III Clinical Trial Comparing JS203 Combined With gemcitabine plus oxaliplatin (JS203-GemOx) Versus rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- JS203 in combination with gemcitabine and oxaliplatin, Rituximab in combination with gemcitabine and oxaliplatin
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS203 in combination with gemcitabine and oxaliplatinCombination product
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 oxaliplatinCombination product
Rituximab and gemcitabine and oxaliplatin 8 cycles (Q3W)
| Study group | Role | What they receive |
|---|---|---|
| JS203+Gemox | Experimental | Not described Receives: Combination Product: JS203 in combination with gemcitabine and oxaliplatin |
| Rituximab+Gemox | Active comparator | Not described Receives: Combination Product: Rituximab in combination with gemcitabine and oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival (OS) evaluated based on 2014 Lugano criteria
Measured: up to approximately 24 months
Secondary outcomes (8)
Objective response rate (ORR)
Objective response rate (ORR) based on 2014 Lugano criteria
Measured: up to approximately 12 months
complete response (CR)
The complete response rate (CR) evaluated based on 2014 Lugano criteria
Measured: up to approximately 12 months
Duration of response (DoR)
Duration of response (DoR) evaluated based on 2014 Lugano criteria
Measured: up to approximately 12 months
Duration of complete response (DoCR)
Duration of complete response (DoCR) evaluated based on 2014 Lugano criteria
Measured: up to approximately 12 months
Adverse events (AE)
Incidence and severity of all adverse events (AE) that occurred during the clinical trial
Measured: up to approximately 15 months
PK
The serum drug concentration of JS203
Measured: up to approximately 15 months
ADA
The incidence and titer of the anti-drug antibody (ADA) of JS203
Measured: up to approximately 15 months
NAb
The incidence of neutralizing antibodies (NAb) of JS203 (if applicable)
Measured: up to approximately 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start8 Oct 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808827
- Sponsor's protocol ID
- JS203-003-III-DLBCL
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07808827
- Acronym / sponsor ID
- JS203-003-III-DLBCL
- Conditions
- Diffuse Large B-Cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A Randomized Open-Label Multicenter Phase III Clinical Trial Comparing JS203 Combined With gemcitabine plus oxaliplatin (JS203-GemOx) Versus rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JS203+Gemox | Experimental | Combination Product: JS203 in combination with gemcitabine and oxaliplatin |
| Rituximab+Gemox | Active comparator | Combination Product: Rituximab in combination with gemcitabine and oxaliplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS203 in combination with gemcitabine and oxaliplatingemcitabine and oxaliplatin 8 cycles (Q3W) and JS203 (21 days/cycle) Cycle 1 QW,Cycle 2 and therafter Q3W for up to 1 year | Combination product | JS203+Gemox |
| Rituximab in combination with gemcitabine and oxaliplatinRituximab and gemcitabine and oxaliplatin 8 cycles (Q3W) | Combination product | Rituximab+Gemox |
Primary outcome
Overall survival (OS)
Time frame: up to approximately 24 months
Overall survival (OS) evaluated based on 2014 Lugano criteria
8 secondary outcomes
Objective response rate (ORR)
Time frame: up to approximately 12 months
complete response (CR)
Time frame: up to approximately 12 months
Duration of response (DoR)
Time frame: up to approximately 12 months
Duration of complete response (DoCR)
Time frame: up to approximately 12 months
Adverse events (AE)
Time frame: up to approximately 15 months
PK
Time frame: up to approximately 15 months
ADA
Time frame: up to approximately 15 months
NAb
Time frame: up to approximately 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JS203 in combination with gemcitabine and oxaliplatin and Rituximab in combination with gemcitabine and oxaliplatin in people with Diffuse Large B-Cell Lymphoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niannian Wang (13161547878, niannian_wang@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.