Expanded Access Program for Epcoritamab

• Conditions: Primary Mediastinal Large B-cell Lymphoma (PMBCL); Grade 3B Follicular Lymphoma; Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; Large B-cell Lymphoma; High Grade B-cell Lymphoma (HGBCL)

• Registration Number: NCT05733650
• Lead Sponsor: Genmab

Brief 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.

Study Timeline

• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-17
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified