Expanded Access Program for Epcoritamab

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ClinicalTrials.gov Identifier: NCT05733650

Expanded Access Status : Approved for marketing

First Posted : February 17, 2023

Last Update Posted : May 25, 2023

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Sponsor:

Collaborator:

AbbVie

Information provided by (Responsible Party):

Genmab

Study Description

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.

Condition or disease	Intervention/treatment
Large B-cell Lymphoma Diffuse Large B-Cell Lymphoma, Not Otherwise Specified Primary Mediastinal Large B-cell Lymphoma (PMBCL) High Grade B-cell Lymphoma (HGBCL) Grade 3B Follicular Lymphoma	Biological: Epcoritamab

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 Design

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Study Type :	Expanded Access
Expanded Access Type :	Treatment IND/Protocol
	See clinical trials of the intervention/treatment in this expanded access record.
Official Title:	Expanded Access Program (EAP) to Provide Epcoritamab (GEN3013) to Eligible Patients With Relapsed or Refractory Large B-cell Lymphoma

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Genetic and Rare Diseases Information Center resources: B-cell Lymphoma Lymphosarcoma Diffuse Large B-Cell Lymphoma Follicular Lymphoma

U.S. FDA: Expanded Access (Compassionate Use)

U.S. FDA Resources

Interventions

Intervention Details:

Biological: Epcoritamab
Eligible patients will receive epcoritamab (28-day cycle) that will be administered as subcutaneous (SC) injections until disease progression, or one or more of the treatment discontinuation criteria are met.
Other Names:
- GEN3013
- DuoBody®-CD3xCD20

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

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Responsible Party:	Genmab
ClinicalTrials.gov Identifier:	NCT05733650
Other Study ID Numbers:	GCT3013-101
First Posted:	February 17, 2023 Key Record Dates
Last Update Posted:	May 25, 2023
Last Verified:	May 2023

Keywords provided by Genmab:


Epcoritamab GEN3013 Diffuse large B-cell lymphoma Lymphoma DuoBody-CD3xCD20 Bispecific antibody Early access	Double-hit DLBCL Triple-hit DLBCL Follicular grade 3b Transformed DLBCL High-grade B-cell lymphoma Primary mediastinal large B-cell lymphoma (PMBCL)

Additional relevant MeSH terms:

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Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms	Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin

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