A Phase 1/2 interventional study of REGN9220 and Odronextamab in Diffuse Large B-Cell Lymphoma (DLBCL), sponsored by Regeneron Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Regeneron Pharmaceuticals · Phase 1/2, Interventional, and Treatment
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:
1,432 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 359 are open to participants now.
This study's planned enrollment of 36 is below the median of 47 across 1,214 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Regeneron Pharmaceuticals is the lead sponsor of 409 studies on the registry; 92 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 79 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
Drug: REGN9220 · Drug: Odronextamab
Administered per the protocol
Administered per the protocol
Also known as: REGN1979, Ordspono™
Occurrence of Dose-Limiting Toxicities (DLTs) during the DLT observation period
Time frame: Up to 28 days
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 2 years
Severity of TEAEs
Time frame: Up to approximately 2 years
Concentration of REGN9220 in serum when given in combination with odronextamab
Time frame: Up to approximately 2 years
Concentration of odronextamab in serum when given in combination with REGN9220
Time frame: Up to approximately 2 years
Occurrence of Anti-Drug Antibodies (ADA) to REGN9220
Time frame: Up to approximately 2 years
Magnitude of ADA to REGN9220
Time frame: Up to approximately 2 years
Occurrence of ADA to odronextamab
Time frame: Up to approximately 2 years
Magnitude of ADA to odronextamab
Time frame: Up to approximately 2 years
Best Overall Response (BOR)
Time frame: Up to 90 days post last study drug administration
Complete Response (CR)
Time frame: Up to 90 days post last study drug administration
Progression-Free Survival (PFS)
Time frame: Up to 90 days post last study drug administration
Duration Of Response (DOR)
Time frame: Up to 90 days post last study drug administration
No study locations are listed for this record.
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Nov 2029, 34 months later.
Of 53 industry-sponsored phase 1/2 interventional studies under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 54 and three quarters within 98. This study's planned 34 months is below that.
Counting every sponsor, half of 110 studies reached it within 73 months; a quarter within 53 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Odronextamab
Lymphoma, Large B-Cell, Diffuse →