NCT07451652

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
16mo left

Started Mar 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
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 Progress10%
Mar 2026Sep 2027

First Submitted

Initial submission to the registry

February 13, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 17, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

February 13, 2026

Last Update Submit

March 26, 2026

Conditions

Relapsed/Refractory Diffuse Large B Cell Lymphoma

Keywords

relapsed/refractory diffuse large B cell lymphomaepcoritamabGemOxgemcitabineoxaliplatinautologous stem cell transplant

Outcome Measures

Primary Outcomes (1)

  • Determine ORR and CR after GemOx plus low-dose Epcoritamab

    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 Outcomes (8)

  • Establish feasibility

    From enrollment up to day 29

  • Describe cytokine release syndrome incidence

    From day 1 up to day 29

  • Describe immune effector cell- associated neurotoxicity syndrome incidence

    From day 1 up to week 10

  • Describe adverse events

    From day 1 up to week 10

  • Determine number of patients that follow through with transplant

    From day one up through study completion, an average of 1 year

  • +3 more secondary outcomes

Study Arms (1)

Epcoritamab + GemOx

EXPERIMENTAL

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: EpcoritamabDrug: Gemcitabine (1000 mg/m2)Drug: Oxaliplatin

Interventions

EpcoritamabDRUG

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)

Epcoritamab + GemOx
Gemcitabine (1000 mg/m2)DRUG

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

Epcoritamab + GemOx
OxaliplatinDRUG

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

Epcoritamab + GemOx

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario "Dr. José Eleuterio González"

Monterrey, Nuevo León, 64640, Mexico

RECRUITING

Related Publications (5)

  • Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8.

    PMID: 34508654BACKGROUND

  • Li T, Gibiansky L, Parikh A, Putnins M, Chiu CW, Sacchi M, Feng H, Ahmadi T, Gupta M, Xu S. Optimal Dosing Regimen for Epcoritamab, a Subcutaneous Bispecific Antibody, in Relapsed or Refractory Large B-Cell Lymphoma. Clin Pharmacol Ther. 2025 May;117(5):1437-1450. doi: 10.1002/cpt.3588. Epub 2025 Feb 11.

    PMID: 39935086BACKGROUND

  • Thieblemont C, Karimi YH, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Jurczak W, Do YR, Gasiorowski R, Lewis DJ, Kim TM, van der Poel M, Poon ML, Feldman T, Linton KM, Sureda A, Hutchings M, Dinh MH, Kilavuz N, Soong D, Mark T, Sacchi M, Phillips T, Lugtenburg PJ. Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial. Leukemia. 2024 Dec;38(12):2653-2662. doi: 10.1038/s41375-024-02410-8. Epub 2024 Sep 25.

    PMID: 39322711BACKGROUND

  • Izutsu K, Kumode T, Yuda J, Nagai H, Mishima Y, Suehiro Y, Yamamoto K, Fujisaki T, Ishitsuka K, Ishizawa K, Ikezoe T, Nishikori M, Akahane D, Fujita J, Dinh M, Soong D, Noguchi H, Buchbjerg JK, Favaro E, Fukuhara N. Subcutaneous epcoritamab monotherapy in Japanese adults with relapsed/refractory diffuse large B-cell lymphoma. Cancer Sci. 2023 Dec;114(12):4643-4653. doi: 10.1111/cas.15996. Epub 2023 Nov 3.

    PMID: 37921363BACKGROUND

  • Brody JD, Jorgensen J, Belada D, Costello R, Trneny M, Vitolo U, Lewis DJ, Karimi YH, Sureda A, Andre M, Wahlin BE, Lugtenburg PJ, Jiang T, Karagoz K, Steele AJ, Abbas A, Wang L, Risum M, Cordoba R. Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial. Blood. 2025 Apr 10;145(15):1621-1631. doi: 10.1182/blood.2024026830.

    PMID: 39792928BACKGROUND

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

GemcitabineOxaliplatin

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 Chemicals

Study Officials

  • Perla R Colunga-Pedraza, MD

    Hospital Universitario "Dr. José Eleuterio González"

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Perla R Colunga-Pedraza, MD

CONTACT

+52 8110761973alrep_rcp@gmail.com

Natalia Huergo-Treviño, MD

CONTACT

+524442416594nat.hue94@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

February 13, 2026

First Posted

March 5, 2026

Study Start

March 17, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

ME(1)