Study on Epcoritamab and Loncastuximab Tesirine for Treating Relapsed or Refractory Large B-cell Lymphoma

Sponsor: University of Miami

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06919939

This clinical trial is testing a new combination of drugs, Epcoritamab and Loncastuximab Tesirine, to see if they can effectively reduce or eliminate lymphoma cells in patients with large B-cell lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining two drugs, Loncastuximab Tesirine and Epcoritamab, is safe and effective in treating large B-cell lymphoma that has come back or hasn't responded to other treatments. Researchers want to see if this combination can help reduce or eliminate lymphoma cells in the body.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Willing and able to sign a consent form and follow the study protocol.
  • Diagnosed with relapsed or refractory large B-cell lymphoma, including specific subtypes like diffuse large B-cell lymphoma or high-grade B-cell lymphoma.
  • Have received at least one previous treatment for lymphoma, including specific types of chemotherapy.
  • Have measurable disease, meaning at least one tumor that can be measured by scans.
  • In good general health with an ECOG performance status of 0 to 2.
  • Have adequate blood, liver, and kidney function based on recent tests.
  • Agree to use effective birth control during the study and for 12 months after the last treatment.
  • If HIV positive, must be stable on treatment with a good immune system and undetectable viral load.
  • Life expectancy of at least 12 weeks.
  • If taking steroids, must be on a low dose before starting the study treatment.

Exclusion Criteria

  • Lymphoma involving the brain or spinal cord.
  • Previous treatment with certain types of cell therapies or antibodies.
  • Previous stem cell transplant.
  • Significant lung or heart disease that affects daily activities.
  • Pregnant or breastfeeding.
  • Not fully recovered from recent major surgery.
  • Active infections requiring treatment or recent severe infections.
  • Recent live vaccine or need for one during the study.
  • Active hepatitis B or C infection.
  • Active COVID-19 infection or recent symptoms without negative tests.
  • Severe lung disease or other serious medical conditions that could affect treatment.
  • Seizure disorder requiring treatment with recent seizures.
  • Difficulty making informed decisions.

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