Expanded Access Program for Epcoritamab

Expanded Access Program (EAP) to Provide Epcoritamab (GEN3013) to Eligible Patients With Relapsed or Refractory Large B-cell Lymphoma

NCT05733650•Genmab

View on ClinicalTrials.gov

Summary

The purpose of this program is to provide investigational epcoritamab, an antibody also known as GEN3013 (DuoBody-CD3xCD20), in an expanded access setting for eligible patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) who have a high unmet medical need with no other treatment options. It is a requirement that patients do not qualify for an ongoing epcoritamab clinical program or are unable to participate due to logistical reasons. Access to investigational epcoritamab can be requested by contacting preapprovalaccessprograms@genmab.com.

Detailed Description

This is a multicenter program conducted within the United States. The program will consist of screening, treatment (Cycle 1 Day 1 until epcoritamab discontinuation), safety follow-up, post-treatment and/or survival follow-up.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must be 18 years of age or older
•R/R CD20+ mature B-cell neoplasm
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2
•≥ 2 prior lines of antineoplastic therapy, including ≥ 1 anti-CD20 monoclonal antibody (mAb)
•Fluorodeoxyglucose (FDG) positron emission tomography (PET)-avid and measurable disease by computed tomography/magnetic resonance imaging (CT/MRI)
•Patients considering the EAP should have no other available therapeutic option and cannot be eligible for other epcoritamab trials.
•Patients considering the EAP must be located in proximity to a US site given that the EAP is currently available only in the United States.
•Prior to initiating any program-related assessments or procedures, patients (or their legally acceptable representative) must sign an informed consent form (ICF), which indicates the purpose of the program, the procedures required for the program, and confirms the patient's willingness to participate in the program.

Exclusion Criteria

•Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20
•Prior treatment with CAR-T therapy within 100 days prior to first epcoritamab administration
•Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma
•Confirmed history of or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. Low-dose prednisolone for rheumatoid arthritis or similar conditions is allowed.
•Active hepatitis B or hepatitis C
•Known clinically significant cardiac disease
•Pregnancy or breastfeeding
•Known hypersensitivity to allopurinol or rasburicase

Key Dates

Last Updated

May 25, 2023

Conditions

Large B-cell LymphomaDiffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedPrimary Mediastinal Large B-cell Lymphoma (PMBCL)High Grade B-cell Lymphoma (HGBCL)Grade 3B Follicular Lymphoma

Interventions

Epcoritamab

BIOLOGICAL

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

View study

RECRUITINGPHASE1

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

NCT06026319

Non-hodgkin LymphomaRelapsed Non-Hodgkin Lymphoma+8 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Expanded Access Program for Epcoritamab

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma

Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma