AzTrials
AzTrials

Relapsed/Refractory Diffuse Large B Cell LymphomaPhase 2NCT07451652

Low Dose Epcoritamab Plus GemOx in R/R DLBCL

A Phase 2 study testing Epcoritamab, Gemcitabine (1000 mg/m2) and Oxaliplatin in people with Relapsed/Refractory Diffuse Large B Cell Lymphoma, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Epcoritamab, Gemcitabine (1000 mg/m2) and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteMexico
Study dates
17 Mar 2026to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Perla R Colunga-Pedraza, MD contact

+52 8110761973

alrep_rcp@gmail.com

Natalia Huergo-Treviño, MD contact

+524442416594

nat.hue94@gmail.com

Mexico1 site, 1 recruiting

  • Hospital Universitario "Dr. José Eleuterio González"

    Monterrey, Nuevo León, 64640

    Recruiting

Other trials in Mexico

About this study

Official title: 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.

Being tested
Epcoritamab, Gemcitabine (1000 mg/m2), Oxaliplatin
Keywords
relapsed/refractory diffuse large B cell lymphoma, epcoritamab, GemOx, gemcitabine, oxaliplatin, autologous stem cell transplant
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • Gemcitabine (1000 mg/m2)Drug

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

  • OxaliplatinDrug

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

Study groups in NCT07451652
Study groupRoleWhat they receive
Epcoritamab + GemOxExperimentalSubjects will receive Gemcitabine/Oxaliplatin at usual doses as well as Epcoritamab with 2 step up doses followed by 12 mg weekly for 3 cycles.
Receives: Drug: Epcoritamab; Drug: Gemcitabine (1000 mg/m2); Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From enrollment to the end of treatment at 14 weeks

Secondary outcomes (8)

  1. Establish feasibility

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

    Measured: From enrollment up to day 29

  2. Describe cytokine release syndrome incidence

    Describe the number of subjects who develop grade 2-4 cytokine release syndrome during the first cycle of treatment

    Measured: From day 1 up to day 29

  3. Describe immune effector cell- associated neurotoxicity syndrome incidence

    Describe the number of subjects that develop immune effector cell-associated neurotoxicity syndrome

    Measured: From day 1 up to week 10

  4. Describe adverse events

    Describe the number of subjects that develop any adverse events

    Measured: From day 1 up to week 10

  5. Determine number of patients that follow through with transplant

    Determine the number of patients that go through with stem cell transplant after finishing 3 cycles of Epcoritamab + GemOx

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

  6. Duration of response

    Determine the duration of response

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

  7. Progression free survival

    Report the subjects´ progression free survival

    Measured: From week 18 up to six and twelve months

  8. Overall survival

    Report the overall survival

    Measured: From day 1 to twelve months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study start17 Mar 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07451652
Sponsor's protocol ID
HE26-00003
Status last verified
Mar 2026
First submitted
13 Feb 2026
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34508654

  • 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.

    PubMed 39935086

  • 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.

    PubMed 39322711

  • 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.

    PubMed 37921363

  • 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.

    PubMed 39792928

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epcoritamab, Gemcitabine (1000 mg/m2) and Oxaliplatin in people with Relapsed/Refractory Diffuse Large B Cell Lymphoma, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Perla R Colunga-Pedraza, MD (+52 8110761973, alrep_rcp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine ORR and CR after GemOx plus low-dose Epcoritamab (time frame: From enrollment to the end of treatment at 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07451652, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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