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Testing a new drug called odronextamab for treating follicular lymphoma

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)

PHASE3 · Regeneron Pharmaceuticals · NCT06091254

This study is testing a new drug called odronextamab to see if it can safely and effectively treat people with follicular lymphoma who haven't received treatment before.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment822 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals (industry)
Drugs / interventionsodronextamab, rituximab, chemotherapy
Locations190 sites (Tucson, Arizona and 189 other locations)
Trial IDNCT06091254 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of odronextamab, an experimental drug, in patients with previously untreated follicular lymphoma. The study consists of two parts: the first part assesses the safety and tolerability of odronextamab alone, while the second part compares its effectiveness to the standard treatment of rituximab combined with chemotherapy. Participants will be monitored for side effects, drug levels in the blood, and the body's immune response to the drug. The goal is to determine if odronextamab can provide a better treatment option for this type of cancer.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with CD20+ follicular lymphoma, stage II bulky or stage III/IV, who require treatment.

Not a fit: Patients with central nervous system lymphoma, high-grade transformations, or those who have received prior systemic anti-lymphoma therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new and potentially more effective treatment option for patients with follicular lymphoma.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific use of odronextamab in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV
2. Need for treatment as described in the protocol
3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
5. Adequate bone marrow function and hepatic function, as described in the protocol

Key Exclusion Criteria:

1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
4. Treatment with any systemic anti-lymphoma therapy
5. Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol

NOTE: Other protocol defined inclusion/exclusion criteria apply

Where this trial is running

Tucson, Arizona and 189 other locations

+140 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Follicular Lymphoma, Non-Hodgkin lymphomas, Indolent NHL, B-cells NHL, Follicular lymphoma, Odronextamab

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.