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Testing a new drug combination for aggressive B-cell lymphoma

A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1)

Phase 1 Interventional Regeneron Pharmaceuticals · NCT05685173

This study is testing a new combination of two experimental drugs to see if they can help adults with aggressive B-cell lymphoma that hasn’t responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment107 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionsodronextamab, prednisone
Locations20 sites (Duarte, California and 19 other locations)
Trial IDNCT05685173 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and tolerability of an experimental drug, REGN5837, in combination with another experimental drug, odronextamab, for adult patients with aggressive B-cell non-Hodgkin lymphomas that have relapsed or are refractory. The study aims to determine the recommended dose for future phases while assessing side effects, drug levels in the blood, and the body's immune response to the drugs. Participants will undergo evaluations to measure the effectiveness of the treatment against their condition.

Who should consider this trial

Good fit: Ideal candidates are adults with documented CD20+ aggressive B-NHL who have experienced disease progression after at least two lines of systemic therapy.

Not a fit: Patients who have undergone allogeneic stem cell transplantation or solid organ transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with aggressive B-cell non-Hodgkin lymphomas that have not responded to previous therapies.

How similar studies have performed: While this approach is novel, similar studies targeting aggressive B-cell lymphomas have shown promise in the past.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Have documented CD20+ aggressive B-NHL, with disease that has progressed after at least 2 lines of systemic therapy containing an anti-CD20 antibody and an alkylating agent, as described in the protocol.
2. Measurable disease on cross sectional imaging as defined in the protocol
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
4. Adequate bone marrow, renal and hepatic function as defined in the protocol
5. 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
6. During dose expansion phase of the study, participant should be willing to undergo mandatory tumor biopsies, if in the opinion of the investigator, the participant has an accessible lesion that can be biopsied without significant risk to the participant.

Key Exclusion Criteria:

1. Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab
2. Diagnosis of Mantle Cell Lymphoma (MCL)
3. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the protocol
4. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter, as described in the protocol
5. Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol
6. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab
7. Co-morbid conditions, as described in the protocol
8. Infections, as described in the protocol
9. Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicase

NOTE: Other protocol defined inclusion / exclusion criteria apply

Where this trial is running

Duarte, California and 19 other locations

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-Hodgkins LymphomaAggressive B-Cell Non-Hodgkin LymphomasRelapsed or Refractory
Last reviewed 2026-06-09 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.