Expanded Access Program for Epcoritamab

Sponsor
Genmab
Study ID
NCT05733650
Status
Approved For Marketing

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epcoritamab — BIOLOGICAL
    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.

Study Details

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 [email protected].

Key Dates

First listed
Feb 17, 2023
Status verified
May 2023

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