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Testing the safety of two experimental drugs for aggressive B-cell lymphoma

A Phase 1 Study to Assess Safety and Tolerability of Odronextamab (REGN1979) an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, and Cemiplimab (REGN2810), an Anti-Programmed Death-1 Monoclonal Antibody in Patients With B-Cell Malignancies (CLIO-1)

Phase 1 Interventional Regeneron Pharmaceuticals · NCT02651662

This study is testing a combination of two new drugs to see if they are safe and effective for adults with aggressive B-cell lymphoma that hasn't responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment62 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionsodronextamab, cemiplimab
Locations39 sites (Santa Monica, California and 38 other locations)
Trial IDNCT02651662 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and tolerability of a combination of two experimental drugs, odronextamab and cemiplimab, in adult patients with relapsed or refractory aggressive B-cell lymphoma. The research aims to determine the recommended dose regimen for these drugs while assessing their effectiveness and potential side effects. Additionally, the study will evaluate how the body responds to the drugs, including the production of antibodies that may affect treatment outcomes. Participants will undergo regular monitoring and assessments throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults with documented CD20+ aggressive B-cell non-Hodgkin lymphoma that has relapsed after at least two prior lines of systemic therapy.

Not a fit: Patients with primary central nervous system lymphoma or those with known CNS involvement by non-primary CNS NHL 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 lymphoma who have not responded to previous therapies.

How similar studies have performed: Other studies have shown promise with similar combinations of immunotherapies, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Have documented CD20+ aggressive B-cell NHL that is either not responsive to or relapsed after at least 2 prior lines of systemic therapy, for whom treatment with an anti-CD20 antibody may be appropriate. In addition, prior treatments should at least contain an anti-CD20 antibody and an alkylating agent.
2. Must have at least 1 nodal lesion (≥1.5 cm), or at least one extranodal lesion with longest transverse diameter (LDi) greater than 1.0 cm, documented by diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]).
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
4. Adequate bone marrow and hepatic function, as defined in the protocol
5. Willing and able to comply with clinic visits and study-related procedures
6. Provide signed informed consent

Key Exclusion Criteria:

1. Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by non-primary CNS NHL
2. History of or current relevant CNS pathology, as described in the protocol
3. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (iAEs)
4. Prior therapies, as described in the protocol
5. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or other uncontrolled infection
6. Cytomegalovirus infection as noted by detectable levels on peripheral blood polymerase chain reaction (PCR) assay until the infection is well controlled.
7. Known hypersensitivity to both allopurinol and rasburicase
8. Pregnant or breastfeeding women
9. Women of childbearing potential, or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose, as defined in the protocol
10. Patients prior diagnosis of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Where this trial is running

Santa Monica, California and 38 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 Relapsed/Refractory Aggressive B-Cell LymphomaB-Cell Non-Hodgkin Lymphoma
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.