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NCT Number: NCT07451652

Low Dose Epcoritamab Plus GemOx in R/R DLBCL

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.

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Key information

Conditions

Relapsed/Refractory Diffuse Large B Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario "Dr. José Eleuterio González"

Monterrey, Nuevo León, 64640, Mexico

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epcoritamab

Drug

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)

Gemcitabine (1000 mg/m2)

Drug

Subjects will receive gemcitabine 1000 mg/m2 on days 1 and 15 of the three 21-day cycles.

Oxaliplatin

Drug

Subjects will receive oxaliplatin 100 mg/m2 on day 1 of three 21-day cycles.

Primary outcomes

  1. 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

Secondary outcomes

  1. Establish feasibility

    Time frame: From enrollment up to day 29

    Determine the number of subjects that complete the first cycle without need for hospitalization

  2. 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

  3. 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

  4. Describe adverse events

    Time frame: From day 1 up to week 10

    Describe the number of subjects that develop any adverse events

  5. 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

  6. Duration of response

    Time frame: From week 18 through study completion, an average of 1 year

    Determine the duration of response

  7. Progression free survival

    Time frame: From week 18 up to six and twelve months

    Report the subjects´ progression free survival

  8. Overall survival

    Time frame: From day 1 to twelve months

    Report the overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Natalia Huergo-Treviño, MD

CONTACT

[email protected]

+524442416594

Perla R Colunga-Pedraza, MD

CONTACT

[email protected]

+52 8110761973

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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