NCT07808827

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P50-P75 for phase_3

Timeline
42mo left

Started Sep 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Feb 2030

First Submitted

Initial submission to the registry

September 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

September 24, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2030

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

2.2 years

First QC Date

September 2, 2026

Last Update Submit

September 8, 2026

Conditions

Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    Overall survival (OS) evaluated based on 2014 Lugano criteria

    up to approximately 24 months

Secondary Outcomes (8)

  • Objective response rate (ORR)

    up to approximately 12 months

  • complete response (CR)

    up to approximately 12 months

  • Duration of response (DoR)

    up to approximately 12 months

  • Duration of complete response (DoCR)

    up to approximately 12 months

  • Adverse events (AE)

    up to approximately 15 months

  • +3 more secondary outcomes

Study Arms (2)

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

Interventions

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

JS203+Gemox
Rituximab in combination with gemcitabine and oxaliplatinCOMBINATION_PRODUCT

Rituximab and gemcitabine and oxaliplatin 8 cycles (Q3W)

Rituximab+Gemox

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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；

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

GemcitabineOxaliplatinRituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic ChemicalsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Niannian Wang

CONTACT

13161547878niannian_wang@junshipharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 9, 2026

Study Start

September 24, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

February 28, 2030

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)