Phase II Study Comparing Epcoritamab to Observation in Adults with Aggressive B-Cell Lymphomas Not Fully Responding After CD19-Directed CAR-T Therapy

What this Trial Is About

Researchers are evaluating epcoritamab, a bispecific antibody, compared to standard observation for patients with aggressive B-cell lymphomas who have not achieved complete remission after treatment with CD19-directed CAR-T therapy. The study aims to compare complete response rates and other outcomes such as progression-free survival, event-free survival, overall survival, and safety between patients receiving epcoritamab and those under observation. This phase II trial focuses on patients with partial response following CAR-T therapy and uses Lugano 2014 criteria for assessment. Participants are randomly assigned to one of two groups. One group receives epcoritamab by subcutaneous injection on a detailed schedule across up to 12 cycles every 28 days, unless disease progression or unacceptable toxicity occurs. The other group undergoes observation according to standard care. Both groups undergo MRI at screening, frequent PETCT scans and blood sample collection during the trial, biopsies at screening and end of treatment, and may have additional imaging during follow-up. After completing treatment or observation, participants are followed every 90 days for one year and then every 180 days for up to five years. Researchers monitor complete response status, disease progression, survival rates, duration of response, and safety events. The study involves regular imaging, blood tests, and biopsies to evaluate treatment effects and disease status throughout the trial and follow-up periods.

Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy