NCT05783609

Epcoritamab and Rituximab for First-line Follicular Lymphoma

A Phase 2 Study of Epcoritamab and Rituximab for First-line Treatment of Follicular Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Reid Merryman, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine how effective and safe the combination of rituximab and epcoritamab is in treating patients with Follicular Lymphoma (FL) and who have not received other treatments for their lymphoma. The names of the study drugs involved in this study are: * Rituximab (a type of monoclonal antibody therapy) * Epcoritamab (a T-cell bispecific antibody)

Detailed description

This is an open-label, multicenter, phase II study to evaluate the efficacy and safety of epcoritamab and rituximab for patients with untreated follicular lymphoma (FL). Epcoritamab brings T cells and follicular lymphoma cells close together and activates the T cells to kill the lymphoma cells. Rituximab activates the immune system to kill the lymphoma cells. The U.S. Food and Drug Administration (FDA) has not approved epcoritamab as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved rituximab as a treatment option for follicular lymphoma (FL). The research study procedures include screening for eligibility, study treatment with evaluations, blood tests, bone marrow biopsies, and Computerized Tomography (CT) scans and Positron Emission Tomography (PET) scans. Participants will receive study treatment for approximately 9-10 months and will be followed for up to 10 years. It is expected that about 100 people will take part in this research study, 35 participants in the initial cohort and 65 patients in the expansion cohort. Genmab and AbbVie are supporting this research study by providing one of the study drugs, Epcoritamab. Genmab is providing funding for the study.

Conditions

• Follicular Lymphoma
• Low Grade Non-Hodgkin's Lymphoma, Adult

Interventions

Type	Name	Description
DRUG	Epcoritamab	T-cell bispecific antibody, via subcutaneous injection
DRUG	Rituximab	Chimeric anti-CD20 monoclonal antibody, via IV infusion

Timeline

• Start date: 2023-06-21
• Primary completion: 2028-02-01
• Completion: 2030-02-01
• First posted: 2023-03-24
• Last updated: 2025-12-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study