NCT06563596

Epco, Zanu, Ritux for R/R FL or MZL

A Phase 2 Study of Epcoritamab, Zanubrutinib, and Rituximab (EZR) for Treatment of Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (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 epcoritamab, zanubrutinib, and rituximab is in treating participants with relapse or refractory Follicular Lymphoma (FL) or marginal zone lymphoma (MZL). * The names of the study drugs involved in this research study are: * Epcoritamab (a type of antibody) * Zanubrutinib (a type of Bruton tyrosine kinase inhibitor) * Rituximab (a type of monoclonal antibody)

Detailed description

This is an open-label, multicenter, phase II study to evaluate the efficacy and safety of epcoritamab, zanubrutinib, and rituximab (EZR) for participants with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The trial will commence with a six participant lead-in cohort for each disease type. The U.S. Food and Drug Administration (FDA) has approved epcoritamab for people who have received at least 2 prior treatments for follicular lymphoma. Epcoritamab is not approved for patients with marginal zone lymphoma. The U.S. FDA has approved zanubrutinib (in combination with a drug called obinutuzumab) for people who have received at least 2 prior treatments for follicular lymphoma. Zanubrutinib is approved for patients with marginal zone lymphoma who have received at lest 1 prior treatment. The FDA has also approved rituximab as a treatment option for follicular lymphoma and marginal zone lymphoma. The research study procedures include screening for eligibility, in-clinic visits, urine tests, blood tests, stool samples, saliva samples, electrocardiograms (ECGs), bone marrow biopsies, Computerized Tomography (CT) scans, Positron Emission Tomography (PET) scans, and questionnaires. Participants will receive study treatment for approximately 12 months and will be followed every 6 months thereafter for up to 10 years. It is expected that about 45 people will take part in this research study (24 FL participants and 21 MZL participants). Genmab is supporting this research study by providing the study drug, epcoritamab, and funding for the study. BeOne Medicines, Inc. is supporting this research study by providing the study drug, zanubrutinib, and funding for the study.

Conditions

• Follicular Lymphoma
• Lymphoma
• Non-Hodgkin Lymphoma
• Relapsed Lymphoma
• Refractory Lymphoma
• Marginal Zone Lymphoma

Interventions

Type	Name	Description
DRUG	Zanubrutinib	Bruton tyrosine kinase inhibitor, 80 mg immediate-release capsule, taken orally per protocol.
DRUG	Rituximab	Chimeric anti-CD20 monoclonal antibody, 10 or 50 mL single-use vials, via intravenous infusion per institutional standard.
DRUG	Epcoritamab	Bispecific antibody, 5 or 60 mg/mL vials, via subcutaneous (under the skin) injection per protocol.

Timeline

• Start date: 2025-01-21
• Primary completion: 2028-03-01
• Completion: 2030-03-01
• First posted: 2024-08-21
• Last updated: 2026-02-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study