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Comparing the effectiveness of odronextamab to standard care for aggressive B-cell lymphoma

A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Versus Standard of Care Therapy in Participants With Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (OLYMPIA-4)

Phase 3 Interventional Regeneron Pharmaceuticals · NCT06230224

This study is testing a new drug called odronextamab to see if it works better than standard treatment for adults with aggressive B-cell lymphoma that hasn't responded to previous therapies.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment216 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionsodronextamab
Locations62 sites (Liverpool, New South Wales and 61 other locations)
Trial IDNCT06230224 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of an experimental drug called odronextamab in adult patients with previously treated aggressive B-cell non-Hodgkin lymphoma that has either relapsed or become refractory to treatment. Participants will receive odronextamab alone, and the study will compare its effects to standard care. Researchers will also assess side effects, blood levels of the drug, the body's immune response to it, and its impact on patients' quality of life and daily activities. The trial aims to provide insights into the potential benefits of odronextamab for this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically proven aggressive B-cell non-Hodgkin lymphoma who have experienced relapse or refractory disease after prior treatment.

Not a fit: Patients who have not received prior treatment with an anti-CD20 antibody or those with other types of lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with aggressive B-cell non-Hodgkin lymphoma who have limited treatment options.

How similar studies have performed: Other studies have shown promise with bispecific antibodies in treating similar conditions, suggesting potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Histologically proven aggressive B-NHL, as described in the protocol. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed
2. Have primary refractory or relapse 12 months or less (≤) from initiation of frontline therapy Only patients who received 1 prior line of therapy containing an anti-Cluster of Differentiation 20 (CD20) antibody and anthracycline are allowed for enrollment
3. Have measurable disease with at least one nodal lesion with longer diameter (LDi) greater than 1.5 cm or at least one extranodal lesion with LDi greater than 1.0 cm, documented by diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\])
4. Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
6. Adequate hematologic and organ function.

Key Exclusion Criteria:

1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol
2. History of or current relevant CNS pathology, as described in the protocol
3. A malignancy other than NHL unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated
4. Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol
5. Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol
6. Allergy/hypersensitivity to study drug, or excipients.

NOTE: Other protocol defined inclusion / exclusion criteria apply

Where this trial is running

Liverpool, New South Wales and 61 other locations

+12 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 → Find more trials like this →
Conditions B-Cell Non-Hodgkin LymphomaNon-Hodgkin lymphomasAggressive NHLOdronextamabAnti-CD20 × anti-CD3 bispecific antibodyRelapsed/Refractory NHL
Last reviewed 2026-06-13 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.