NCT05733650

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

First QC Date

January 23, 2023

Last Update Submit

May 23, 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

Keywords

EpcoritamabGEN3013Diffuse large B-cell lymphomaLymphomaDuoBody-CD3xCD20Bispecific antibodyEarly accessDouble-hit DLBCLTriple-hit DLBCLFollicular grade 3bTransformed DLBCLHigh-grade B-cell lymphomaPrimary mediastinal large B-cell lymphoma (PMBCL)

Interventions

EpcoritamabBIOLOGICAL

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.

Also known as: GEN3013, DuoBody®-CD3xCD20

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 17, 2023

Last Updated

May 25, 2023

Record last verified: 2023-05