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Comparing two treatments for relapsed or refractory diffuse large B-cell lymphoma

A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Phase 3 Interventional Genmab · NCT06508658

This study is testing a new combination of two treatments for adults with relapsed or refractory diffuse large B-cell lymphoma to see if it works better than the standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment320 (estimated)
Ages18 Years and up
SexAll
SponsorGenmab Industry-sponsored
Drugs / interventionsrituximab, CAR-T, chimeric antigen receptor, chemotherapy, epcoritamab
Locations122 sites (Los Angeles, California and 121 other locations)
Trial IDNCT06508658 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of subcutaneously injected epcoritamab combined with oral lenalidomide against the intravenous administration of rituximab, gemcitabine, and oxaliplatin in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Approximately 320 participants will be enrolled across 165 sites globally, with participants assigned to one of two treatment arms. The study will monitor adverse events and changes in disease condition over a treatment period of up to 12 cycles, each lasting 28 days.

Who should consider this trial

Good fit: Ideal candidates include adults with histologically confirmed CD20+ DLBCL who have relapsed or refractory disease after at least one line of systemic therapy.

Not a fit: Patients who have not been previously treated for DLBCL or those with other types of lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with relapsed or refractory DLBCL.

How similar studies have performed: Other studies have shown promising results with similar treatment approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Eastern Cooperative Oncology Group Performance status score of 0 to 2.
* Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organization (WHO) 2022 as per the protocol.
* Must have relapsed or refractory (R/R) disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis.
* . Participant must meet at least 1 of the following criteria:

  * Failed prior autologous stem cell transplant (ASCT), defined as relapsed after ASCT or been refractory to ASCT.
  * Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT.
  * Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) meeting at least 1 of the following criteria:

    * Unable to receive CAR-T therapy due to fitness and/or comorbidity.
    * Lymphocyte apheresis failure.
    * Unwilling to receive CAR-T therapy.
    * Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints.
    * Relapsed/progressed after having achieved at least a Partial Response (PR) or Complete Response (CR) while on prior CAR-T therapy.
* Must have measurable disease.
* Life expectancy \> 3 months on standard of care treatment at the time of enrolling in the study

Exclusion Criteria:

* Current evidence of primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening.
* History of prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx) or gemcitabine and oxaliplatin (GemOx).
* Documented refractoriness to lenalidomide.

Where this trial is running

Los Angeles, California and 121 other locations

+72 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diffuse Large B-Cell LymphomaEpcoritamabLenalidomideRituximabGemcitabineOxaliplatinDLBCLEpkinly
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.