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

NCT07887750 | Not Yet Recruiting Phase 1 FDA Drug

• 3 other identifiers: R9220-HM-25592025-524780-20-002025
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Keywords

Aggressive B-Cell Non-Hodgkin Lymphoma (B-NHL)

Outcome Measures

Primary Outcomes (3)

• 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 (10)

• 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

Study Arms (1)

REGN9220 + Odronextamab

EXPERIMENTAL

Drug: REGN9220; Drug: Odronextamab

Interventions

REGN9220 DRUG

Administered per the protocol

REGN9220 + Odronextamab

Odronextamab DRUG

Administered per the protocol

Also known as: REGN1979, Ordspono™

REGN9220 + Odronextamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): December 7, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf