Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma

• Status: Not yet recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Epcoritamab (also known as GEN3013 and DuoBody®-CD3xCD20) is an antibody that has already been tested in several clinical studies. All patients will receive active treatment. There is an equal chance of receiving epcoritamab or epcoritamab plus lenalidomide.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genmab
• Collaborator: AbbVie
• Treatments: Lenalidomide

Criteria

Inclusion Criteria:

• Must have newly diagnosed CD20+ large cell lymphoma.

• Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to:

• Being age ≥80 years; AND/OR

• Being age ≥75 years and having important comorbid condition(s), which are likely to have a negative impact on tolerability of anthracycline-based therapy/cytotoxic chemotherapy.

• Have Immune Effector Cell-Associated Encephalopathy (ICE) score of at least 8 out of 10.

• Have Ann Arbor Stage II-IV disease.

• Have ECOG PS of 0, 1, or 2; (ECOG PS of 3 may be considered if impairment is attributed to current lymphoma/DLBCL and if pre-phase treatment during the screening phase results in an improvement of ECOG PS to ≤2 prior to enrollment).

• Have measurable disease as per Lugano criteria.

• Have acceptable organ function based on baseline bloodwork.

• Must have fresh (preferred) or archival biopsy material at screening.

Exclusion Criteria:

• Has known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection at trial enrollment, including COVID-19 infection.

• Has severe cardiovascular disease (other than those eligibility criteria that preclude the subject from receiving anthracycline-based therapy/cytotoxic chemotherapy),

• Has been exposed to/received any of the following prior therapies, treatments, or procedures within the specified timeframes:

• Major surgery within 4 weeks prior to the first dose of epcoritamab;

• Non-investigational antineoplastic agents (except anti-CD20 monoclonal antibodies) or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab;

• Autologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation;

• Live, attenuated vaccines within 30 days prior to initiation of epcoritamab;

• Investigational vaccines within 28 days before the planned first dose of epcoritamab (ie, experimental and/or non-authorized SARS-CoV-2 vaccinations and therapies are not allowed);

• Invasive investigational medical device use within 28 days before the planned first dose of epcoritamab.

• Has primary central nervous system (CNS) tumor or known CNS involvement or intracranial involvement as confirmed by mandatory brain magnetic resonance imaging/computed tomography (MRI/CT) scan at screening and, if clinically indicated, by lumbar puncture.

• Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure within 6 months of signing an informed consent form.

• Has known past or current malignancy other than inclusion diagnosis, with exceptions as stated in protocol.

• Has known or suspected allergies, hypersensitivity, or intolerance to either of the trial treatments or has known or suspected contraindication to the use of all locally available anti-cytokine therapies per local guidelines for management of cytokine release syndrome (CRS).

• Has active hepatitis B virus (HBV) (DNA polymerase chain reaction [PCR]-positive) or hepatitis C virus (HCV) (RNA PCR-positive) infection, current alcohol abuse, or cirrhosis.

• Has active cytomegalovirus (CMV) infection (DNA PCR-positive) requiring treatment.

• Has suspected active or inadequately treated latent tuberculosis.

• Has a known history of seropositivity for HIV. Note: HIV testing is required at screening only if required per local health authorities or institutional standards.

Note: Other protocol defined inclusion/exclusion criteria may apply.