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

September 8, 2026 updated by: Shanghai Junshi Bioscience Co., Ltd.
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

282

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Yuqin Song, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JS203+Gemox
Combination product: 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
Active Comparator: Rituximab+Gemox
Combination product: Rituximab in combination with gemcitabine and oxaliplatin
Rituximab and gemcitabine and oxaliplatin 8 cycles (Q3W)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: up to approximately 24 months
Overall survival (OS) evaluated based on 2014 Lugano criteria
up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: up to approximately 12 months
Objective response rate (ORR) based on 2014 Lugano criteria
up to approximately 12 months
complete response (CR)
Time Frame: up to approximately 12 months
The complete response rate (CR) evaluated based on 2014 Lugano criteria
up to approximately 12 months
Duration of response (DoR)
Time Frame: up to approximately 12 months
Duration of response (DoR) evaluated based on 2014 Lugano criteria
up to approximately 12 months
Duration of complete response (DoCR)
Time Frame: up to approximately 12 months
Duration of complete response (DoCR) evaluated based on 2014 Lugano criteria
up to approximately 12 months
Adverse events (AE)
Time Frame: up to approximately 15 months
Incidence and severity of all adverse events (AE) that occurred during the clinical trial
up to approximately 15 months
PK
Time Frame: up to approximately 15 months
The serum drug concentration of JS203
up to approximately 15 months
ADA
Time Frame: up to approximately 15 months
The incidence and titer of the anti-drug antibody (ADA) of JS203
up to approximately 15 months
NAb
Time Frame: up to approximately 15 months
The incidence of neutralizing antibodies (NAb) of JS203 (if applicable)
up to approximately 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 24, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

February 28, 2030

Study Registration Dates

First Submitted

September 2, 2026

First Submitted That Met QC Criteria

September 8, 2026

First Posted (Actual)

September 9, 2026

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS203-003-III-DLBCL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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