ClinicalTrials.gg
RecruitingNCT07808827Updated Oct 14, 2026

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 interventional study of JS203 in combination with gemcitabine and oxaliplatin and Rituximab in combination with gemcitabine and oxaliplatin in Diffuse Large B-Cell Lymphoma, sponsored by Shanghai Junshi Bioscience Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Shanghai Junshi Bioscience Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 14, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
282
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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.

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

02

Conditions studied

  • Diffuse Large B-Cell Lymphoma
03

In context

Lymphoma, Large B-Cell, Diffuse

1,868 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 355 are open to participants now.

This study's planned enrollment of 282 is above the median of 45 across 1,497 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd. is the lead sponsor of 100 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • : 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 meeting the criteria specified in the Lugano 2014 response assessment;
  • Acceptable organ function at screening;

Exclusion criteria

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 hematopoietic stem cell transplantation;
  • Previous solid organ transplantation
  • History of 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)
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
282 participants (estimated)

Study arms

  • Experimental
    JS203+Gemox

    Combination Product: JS203 in combination with gemcitabine and oxaliplatin

  • Active comparator
    Rituximab+Gemox

    Combination Product: Rituximab in combination with gemcitabine and oxaliplatin

Interventions

06

What researchers measure

Primary outcomes

  1. Overall survival (OS)

    Overall survival (OS) evaluated based on 2014 Lugano criteria

    Time frame: up to approximately 24 months

Secondary outcomes

  1. Objective response rate (ORR)

    Objective response rate (ORR) based on 2014 Lugano criteria

    Time frame: up to approximately 12 months

  2. complete response (CR)

    The complete response rate (CR) evaluated based on 2014 Lugano criteria

    Time frame: up to approximately 12 months

  3. Duration of response (DoR)

    Duration of response (DoR) evaluated based on 2014 Lugano criteria

    Time frame: up to approximately 12 months

  4. Duration of complete response (DoCR)

    Duration of complete response (DoCR) evaluated based on 2014 Lugano criteria

    Time frame: up to approximately 12 months

  5. Adverse events (AE)

    Incidence and severity of all adverse events (AE) that occurred during the clinical trial

    Time frame: up to approximately 15 months

  6. PK

    The serum drug concentration of JS203

    Time frame: up to approximately 15 months

  7. ADA

    The incidence and titer of the anti-drug antibody (ADA) of JS203

    Time frame: up to approximately 15 months

  8. NAb

    The incidence of neutralizing antibodies (NAb) of JS203 (if applicable)

    Time frame: up to approximately 15 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Nov 2028, 25 months after the start.

Of 73 phase 3 interventional studies under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 99. This study's planned 25 months is below that.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 14, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 9, 2026
StartActual
Oct 8, 2026was Sep 2026
Primary completionEst.
Nov 30, 2028
CompletionEst.
Feb 28, 2030
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 14, 2026
Sites
Beijing Cancer Hospital is now Recruiting
Oct 14, 2026
Start date
Sep 24, 2026→Oct 8, 2026 (actual)
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    Not yet recruiting→Recruiting
    Beijing Cancer Hospital is now Recruiting
    Start date Sep 24, 2026→Oct 8, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07808827
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Oct 8, 2026
Primary completion
Nov 30, 2028 (estimated)
Completion
Feb 28, 2030 (estimated)
Last update
Oct 14, 2026

Study contacts

Niannian Wang
Contact
niannian_wang@junshipharma.com
13161547878

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Anti-CD20/CD3 Bispecific Antibody JS203 · Gemcitabine · Oxaliplatin

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