Study on Epcoritamab for Treating Relapsed or Hard-to-Treat Large B-Cell Lymphoma

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06811272

Provider View

This clinical trial is testing the effectiveness of a drug called epcoritamab in patients with large B-cell lymphoma that has returned or not responded to previous treatment. The study is for those who are not eligible for a stem cell transplant.

Patient Parameters

Program Overview

The purpose of this study is to see if the drug epcoritamab can help treat large B-cell lymphoma that has come back or is not responding to treatment. This is a Phase 2 study, which means it is testing how safe and effective the drug is for this condition. Epcoritamab has been approved by the FDA for use after at least two prior treatments. Participants will receive the drug for up to 24 cycles or until the disease progresses, side effects become too severe, or they choose to stop. They will be monitored for up to 24 months after the last dose or until the disease progresses. About 30 people are expected to join this study.

Description

This study is for patients with large B-cell lymphoma that has returned or is not responding to treatment. It involves taking a drug called epcoritamab, which is given to patients who are not eligible for a stem cell transplant. The study will test the safety and effectiveness of epcoritamab, which is already approved for use after at least two prior treatments. Participants will receive the drug for up to 24 cycles, or until the disease progresses, side effects become too severe, or they choose to stop. They will be followed for up to 24 months after the last dose or until the disease progresses. The study aims to include about 30 participants.

Eligibility Criteria

Inclusion Criteria

  • Must have large B-cell lymphoma of specific types, such as Diffuse Large B-Cell Lymphoma (DLBCL) or High Grade B-Cell Lymphoma (HGBCL).
  • Must have measurable disease as shown by scans.
  • Must have had one prior treatment that included specific types of drugs.
  • Must be 18 years or older.
  • Must be in good overall health, with a performance status score between 0 and 2.
  • Must not be a candidate for high-dose chemotherapy and stem cell transplant, or must refuse such treatment.
  • Must have adequate blood counts and organ function.
  • Must be able to stay within 60 minutes of the treatment site for 24 hours after the first dose.
  • Women of childbearing potential must use effective birth control during the study and for 6 months after the last dose.
  • Men must use effective birth control during the study and for 3 months after the last dose.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Must not have used another investigational drug or approved lymphoma therapy within 28 days before the study.
  • Must not have received certain types of previous treatments, like CD20/CD3 bispecific antibodies or CAR T-cell therapy.
  • Must not have active central nervous system involvement by lymphoma.
  • Must not have uncontrolled infections or autoimmune diseases.
  • Must not have severe allergies to similar drugs.
  • Women who are pregnant or breastfeeding cannot participate.
  • Must not have active HIV, hepatitis B, or hepatitis C infections unless well-controlled.
  • Must not have active COVID-19 infection.
  • Must not have received a live vaccine within 28 days before the study.
  • Must not have other active cancers, except for certain types that are not expected to spread.

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