Low Dose Epcoritamab Plus GemOx in R/R DLBCL

March 26, 2026 updated by: Perla Rocío Colunga Pedraza, Hospital Universitario Dr. Jose E. Gonzalez

Low Dose Epcoritamab Plus Gemcitabine/Oxaliplatin in Treatment of Transplant Eligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

In this study, researchers are looking to determine whether Gemcitabine/Oxaliplatin plus a lower dose of Epcoritamab (12 mg) works to treat subjects with relapsed/refractory diffuse large B-cell lymphoma, who are candidates to autologous stem cell transplantation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2

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 Contact Backup

Study Locations

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64640
        • Recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

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:

  • Subjects with relapsed/refractory diffuse large B-cell lymphoma who have received at least 1 previous line of treatment and that are candidates to autologous stem cell transplant
  • ECOG 0-2
  • Women of reproductive age who agree on getting a contraceptive method
  • Subjects who fulfill Lugano´s criteria for disease activity
  • Subjects who voluntarily accept to participate in this study

Exclusion Criteria:

  • Active bacterial, viral or fungal infection
  • Subjects who have already received an autologous o allogeneic stem cell transplantation
  • Subjects with other active neoplasias
  • Subjects with end-stage failure

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epcoritamab + GemOx
Subjects will receive Gemcitabine/Oxaliplatin at usual doses as well as Epcoritamab with 2 step up doses followed by 12 mg weekly for 3 cycles.
Drug: Epcoritamab
Subjects will receive 2 step up doses of Epcoritamab (0.16 mg and 0.8 mg) followed by 12 mg weekly, for a total of three 21-day cycles (8 applications)
Drug: Gemcitabine (1000 mg/m2)
Subjects will receive gemcitabine 1000 mg/m2 on days 1 and 15 of the three 21-day cycles.
Drug: Oxaliplatin
Subjects will receive oxaliplatin 100 mg/m2 on day 1 of three 21-day cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine ORR and CR after GemOx plus low-dose Epcoritamab
Time Frame: From enrollment to the end of treatment at 14 weeks
Determine ORR and CR after 3 cycles of GemOx plus low-dose Epcoritamab based on PET-CT
From enrollment to the end of treatment at 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish feasibility
Time Frame: From enrollment up to day 29
Determine the number of subjects that complete the first cycle without need for hospitalization
From enrollment up to day 29
Describe cytokine release syndrome incidence
Time Frame: From day 1 up to day 29
Describe the number of subjects who develop grade 2-4 cytokine release syndrome during the first cycle of treatment
From day 1 up to day 29
Describe immune effector cell- associated neurotoxicity syndrome incidence
Time Frame: From day 1 up to week 10
Describe the number of subjects that develop immune effector cell-associated neurotoxicity syndrome
From day 1 up to week 10
Describe adverse events
Time Frame: From day 1 up to week 10
Describe the number of subjects that develop any adverse events
From day 1 up to week 10
Determine number of patients that follow through with transplant
Time Frame: From day one up through study completion, an average of 1 year
Determine the number of patients that go through with stem cell transplant after finishing 3 cycles of Epcoritamab + GemOx
From day one up through study completion, an average of 1 year
Duration of response
Time Frame: From week 18 through study completion, an average of 1 year
Determine the duration of response
From week 18 through study completion, an average of 1 year
Progression free survival
Time Frame: From week 18 up to six and twelve months
Report the subjects´ progression free survival
From week 18 up to six and twelve months
Overall survival
Time Frame: From day 1 to twelve months
Report the overall survival
From day 1 to twelve months

Collaborators and Investigators

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

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Principal Investigator: Perla R Colunga-Pedraza, MD, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 17, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE26-00003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Relapsed/Refractory Diffuse Large B Cell Lymphoma

Clinical Trials on Epcoritamab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe