REGN9220 in Combination With Odronextamab in Adult Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphomas (BCNHLs)

NCT07887750 — Phase 1 / Phase 2, Not yet recruiting, 36 participants, Regeneron Pharmaceuticals

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Phase 1 Trial to Investigate the Safety and Tolerability of REGN9220, an Anti-CD22 X Anti-4-1BB Costimulatory Bispecific Monoclonal Antibody, in Combination With Odronextamab, an Anti-CD20 X Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphomas

Registry	NCT07887750
Status	Not yet recruiting
Phase	Phase 1 / Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	36 (Estimated)
Sponsor	Regeneron Pharmaceuticals (Industry)
Conditions	Diffuse Large B-Cell Lymphoma (DLBCL)
Interventions	REGN9220, Odronextamab (Drug)
Dates	start 2026-12-07 (estimated), primary completion 2029-11-01 (estimated), completion 2029-11-01 (estimated), first posted 2026-10-21, last updated 2026-10-21

-Summary

This study will test a new experimental study drug called REGN9220 with a Regeneron drug called odronextamab (both called "study drug") to see if it can help treat people with aggressive BCNHL that has either come back/gotten worse or has not responded to previous treatment.

The study is looking at:

* What side effects REGN9220 might cause when given with odronextamab
* How well REGN9220 works when given with odronextamab
* How much REGN9220 is in the blood at different times when given with odronextamab
* If the body makes antibodies to REGN9220 when given with odronextamab, this may cause the REGN9220 to not work as well
* How the body and immune system changes after having REGN9220 given with odronextamab, which can help researchers understand why REGN9220 given with odronextamab works better in some people than others
* What is the best dose of REGN9220 when given with odronextamab

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+Arms and interventions

Arm	Type	Interventions	Description
REGN9220 + Odronextamab	Experimental	Drug: REGN9220; Drug: Odronextamab

REGN9220 (Drug): Administered per the protocol
Odronextamab (Drug), also known as REGN1979, Ordspono™: Administered per the protocol

+Outcome measures

Primary outcomes

Occurrence of Dose-Limiting Toxicities (DLTs) during the DLT observation period [Up to 28 days]
Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Up to approximately 2 years]
Severity of TEAEs [Up to approximately 2 years]

Secondary outcomes

Concentration of REGN9220 in serum when given in combination with odronextamab [Up to approximately 2 years]
Concentration of odronextamab in serum when given in combination with REGN9220 [Up to approximately 2 years]
Occurrence of Anti-Drug Antibodies (ADA) to REGN9220 [Up to approximately 2 years]
Magnitude of ADA to REGN9220 [Up to approximately 2 years]
Occurrence of ADA to odronextamab [Up to approximately 2 years]
Magnitude of ADA to odronextamab [Up to approximately 2 years]
Best Overall Response (BOR) [Up to 90 days post last study drug administration]
Complete Response (CR) [Up to 90 days post last study drug administration]
Progression-Free Survival (PFS) [Up to 90 days post last study drug administration]
Duration Of Response (DOR) [Up to 90 days post last study drug administration]

+Eligibility

Sex: All, ages: 18 Years to any

Key Inclusion Criteria:

1. Documented Cluster of Differentiation (CD)20+ aggressive B-cell non-Hodgkin lymphoma that is relapsed or refractory
2. Measurable disease on cross sectional imaging
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
4. Adequate organ function (hematologic, hepatic, and renal)
5. Availability of tumor tissue for analysis for submission to central laboratory is required for trial enrollment
6. Willingness to comply with contraception requirements and study procedures

Key Exclusion Criteria:

1. Diagnosis of Mantle Cell Lymphoma (MCL) or Central Nervous System (CNS) lymphoma
2. Significant CNS disorders
3. Active/uncontrolled infections
4. Prior treatment with anti-CD20 x anti-CD3 bispecific antibody
5. Recent cancer therapy or major surgery
6. Drug hypersensitivity
7. Significant comorbidities
8. Pregnancy/breastfeeding

NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply

+Investigators

Clinical Trial Management, Study director, Regeneron Pharmaceuticals

+Funding

NIH grants: 2025