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Expanded Access Program for Epcoritamab

Primary Purpose

Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Epcoritamab
Sponsored by
Genmab
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Large B-cell Lymphoma focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 23, 2023
    Last Updated
    May 23, 2023
    Sponsor
    Genmab
    Collaborators
    AbbVie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05733650
    Brief Title
    Expanded Access Program for Epcoritamab
    Official Title
    Expanded Access Program (EAP) to Provide Epcoritamab (GEN3013) to Eligible Patients With Relapsed or Refractory Large B-cell Lymphoma
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genmab
    Collaborators
    AbbVie

    4. Oversight

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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
    Keywords
    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)

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    Epcoritamab
    Other Intervention Name(s)
    GEN3013, DuoBody®-CD3xCD20
    Intervention Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access Program for Epcoritamab

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