NCT07128641

Odronextamab in Low Tumor Volume Advanced FL

A Phase II Study of Odronextamab in Treatment Naïve Patients With Low Tumor Volume Advanced Stage Follicular Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Gottfried von Keudell, MD PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of treating previously untreated Follicular Lymphoma (FL) with odronextamab. The name of the study drug in this research study is: -Odronextamab (a type of monoclonal antibody)

Detailed description

This prospective, phase 2, single-arm, open label study is to evaluate the safety and effectiveness of Odronextemab in participants with previously untreated Follicular Lymphoma (FL). Odronextemab is a type of immunotherapy is a cancer treatment that uses the body's own immune system to fight cancer cells. The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, Computerized Tomography (CT) scans, Positron Emission (PET) scans, echocardiograms (ECGs), bone marrow biopsies and aspirations, and tumor biopsies. The U.S. Food and Drug Administration (FDA) has not approved odronextamab as a treatment for Follicular Lymphoma. Participants will receive the study drug for up to 6 cycles, or 126 days, and will be followed for up to 15 years. It is expected that about 35 people will take part in this research study. Regeneron Pharmaceuticals, Inc. is supporting this research study by providing the study drug, odronextamab and funding for this study.

Conditions

• Follicular Lymphoma
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Odronextamab	A CD20xCD3 bispecific monoclonal antibody, glass vials, via intravenous (into the vein) infusion per protocol.

Timeline

• Start date: 2025-09-08
• Primary completion: 2027-01-02
• Completion: 2028-01-02
• First posted: 2025-08-19
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study