Home › Trials › NCT05283720

Evaluating Epcoritamab with Other Cancer Treatments for Non-Hodgkin Lymphoma

Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma

Phase 2 Interventional Genmab · NCT05283720

This study is testing if the new drug epcoritamab, when combined with other cancer treatments, can be safe and effective for adults with Non-Hodgkin lymphoma.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment496 (estimated)
Ages18 Years and up
SexAll
SponsorGenmab Industry-sponsored
Drugs / interventionsepcoritamab, polatuzumab, rituximab, ibrutinib, cyclophosphamide, doxorubicin, prednisone
Locations76 sites (Tucson, Arizona and 75 other locations)
Trial IDNCT05283720 on ClinicalTrials.gov

What this trial studies

This study assesses the safety and tolerability of the investigational drug epcoritamab when combined with various anti-neoplastic agents in adults diagnosed with Non-Hodgkin lymphoma. Participants will be grouped into treatment arms, each receiving different combinations of epcoritamab and other medications like Lenalidomide and Ibrutinib. The study aims to evaluate adverse events and changes in disease activity over multiple treatment cycles. Approximately 622 adult participants will be enrolled across 100 global sites.

Who should consider this trial

Good fit: Ideal candidates include adults with specific types of Non-Hodgkin lymphoma, such as diffuse large B-cell lymphoma or follicular lymphoma, who have confirmed CD20+ disease.

Not a fit: Patients with Non-Hodgkin lymphoma types that do not meet the eligibility criteria, such as those with histologically transformed aggressive lymphomas, 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 Non-Hodgkin lymphoma.

How similar studies have performed: Other studies have shown promising results with similar combinations of therapies for Non-Hodgkin lymphoma, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of:

  \-- Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:
  * DLBCL, not otherwise specified (NOS).
  * High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible.
  * Follicular lymphoma (FL) Grade 3B. OR
* FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR
* Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR).
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arm 6A where ECOG performance status must be 0-1.
* Must have 1 or more measurable disease sites:

  * A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND
  * At least 1 measurable nodal lesion (long axis \> 1.5 cm) or \>= 1 measurable extra-nodal lesion (long axis \> 1.0 cm) on CT scan or magnetic resonance imaging (MRI).

Exclusion Criteria:

* Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.
* Toxicities from prior anticancer therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac criteria) must also be met.

Where this trial is running

Tucson, Arizona and 75 other locations

+26 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 Non-Hodgkin LymphomaEpcoritamabLenalidomideIbrutinibPolatuzumab VedotinRituximabCyclophosphamideDoxorubicin Hydrochloride (HCl]
Last reviewed 2026-06-13 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.