Multicenter, Randomized Phase II Study of Epcoritamab for Patients With Aggressive B-Cell Lymphomas Achieving a Partial Response After CD19-Directed CAR-T Therapy

Summary

This phase II trial compares epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Epcoritamab is a bispecific antibody. It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells, which are a type of immune cell. When epcoritamab binds to CD20 and CD3, it brings the two cells together and activates the T-cells to kill the cancerous B-cells. Epcoritamab may increase a patient's chances of achieving complete remission after CD19-directed CAR-T therapy, compared to standard observation.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Procedure
  Biopsy

  Undergo biopsy

• Procedure
  Biospecimen Collection

  Undergo collection of blood samples

• Procedure
  Computed Tomography

  Undergo PET/CT and/or CT

• Biological
  Epcoritamab

  Given SC

• Procedure
  Magnetic Resonance Imaging

  Undergo MRI

• Other
  Patient Observation

  Undergo observation

• Procedure
  Positron Emission Tomography

  Undergo PET/CT

Locations (6)