Diffuse Large B-Cell Lymphoma (DLBCL)Phase 1/2NCT07887750
REGN9220 in Combination With Odronextamab in Adult Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphomas (BCNHLs)
A Phase 1/2 study testing REGN9220 and Odronextamab in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Regeneron Pharmaceuticals.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma (DLBCL)
- What is being tested?
- REGN9220 and Odronextamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2026to 1 Nov 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Significant comorbidities
- Pregnancy/breastfeeding
- NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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)
- Being tested
- REGN9220, Odronextamab
- Keywords
- Aggressive B-Cell Non-Hodgkin Lymphoma (B-NHL)
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN9220Drug
Administered per the protocol
OdronextamabDrug
Also called REGN1979, Ordspono™
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| REGN9220 + Odronextamab | Experimental | Not described Receives: Drug: REGN9220; Drug: Odronextamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose-Limiting Toxicities (DLTs) during the DLT observation period
Measured: Up to 28 days
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to approximately 2 years
Severity of TEAEs
Measured: Up to approximately 2 years
Secondary outcomes (10)
Concentration of REGN9220 in serum when given in combination with odronextamab
Measured: Up to approximately 2 years
Concentration of odronextamab in serum when given in combination with REGN9220
Measured: Up to approximately 2 years
Occurrence of Anti-Drug Antibodies (ADA) to REGN9220
Measured: Up to approximately 2 years
Magnitude of ADA to REGN9220
Measured: Up to approximately 2 years
Occurrence of ADA to odronextamab
Measured: Up to approximately 2 years
Magnitude of ADA to odronextamab
Measured: Up to approximately 2 years
Best Overall Response (BOR)
Measured: Up to 90 days post last study drug administration
Complete Response (CR)
Measured: Up to 90 days post last study drug administration
Progression-Free Survival (PFS)
Measured: Up to 90 days post last study drug administration
Duration Of Response (DOR)
Measured: Up to 90 days post last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start7 Dec 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887750
- Sponsor's protocol ID
- R9220-HM-2559
- Other IDs
- 2025-524780-20-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing