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NCT05283720

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Genmab
~264 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:EpcoritamabLenalidomideIbrutinibRituximabCyclophosphamideDoxorubicin Hydrochloride [HCl]

At a glance

Recruiting sites
0 of 76 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose-Limiting Toxicities (DLT)
Measured over Up to Approximately 5 Years

Conditions

Non-Hodgkin Lymphoma

Explore related trials

Diffuse Large B-Cell LymphomaFollicular LymphomaMantle Cell LymphomaNon-Hodgkin Lymphoma

Where it's being run

76 sites across 54 states
Spain7
Seoul Teugbyeolsi4
North Carolina3
Bavaria3
Taiwan3
New York2
Pennsylvania2
Washington2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of:
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

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.

What this trial measures

  • Number of Participants with Dose-Limiting Toxicities (DLT)Up to Approximately 5 Years

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.