Expanded Access Program for Epcoritamab for Patients with Relapsed or Refractory Large B-Cell Lymphoma

Sponsor: Genmab

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05733650

This program offers access to the investigational drug epcoritamab for patients with relapsed or refractory large B-cell lymphoma who have no other treatment options and cannot join other epcoritamab trials.

Patient Parameters

Program Overview

The goal of this program is to provide the investigational drug epcoritamab, also known as GEN3013 (DuoBody-CD3xCD20), to patients with relapsed or refractory large B-cell lymphoma (LBCL) who have no other treatment options. This program is for patients who cannot join ongoing clinical trials for epcoritamab due to eligibility or logistical reasons. Patients or their doctors can request access to epcoritamab by contacting preapprovalaccessprograms@genmab.com.

Description

This program is available at multiple centers across the United States. It includes several stages: screening, treatment (starting from the first day of receiving epcoritamab until it is stopped), safety follow-up, and post-treatment or survival follow-up. The program is designed to monitor the safety and effectiveness of epcoritamab in patients who have no other treatment options.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have relapsed or refractory CD20+ mature B-cell lymphoma.
  • Have a performance status score of 0, 1, or 2, meaning fully active or with some limitations but able to care for oneself.
  • Have received at least two previous treatments for cancer, including at least one anti-CD20 monoclonal antibody.
  • Have a type of cancer that can be seen on a PET scan and measured by CT or MRI.
  • Have no other available treatment options and cannot join other epcoritamab trials.
  • Must be located near a site in the United States where the program is available.
  • Must sign an informed consent form before starting the program, indicating understanding and willingness to participate.

Exclusion Criteria

  • Have previously received a bispecific antibody targeting CD3 and CD20.
  • Have had CAR-T therapy within 100 days before starting epcoritamab.
  • Have primary central nervous system lymphoma or known lymphoma in the brain.
  • Have a history of autoimmune disease or other conditions that cause permanent immune system suppression, unless on low-dose prednisolone for conditions like rheumatoid arthritis.
  • Have active hepatitis B or C.
  • Have significant heart disease.
  • Are pregnant or breastfeeding.
  • Have known allergies to allopurinol or rasburicase.

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