Recruiting
Phase 3

Odronextamab & Chemotherapy

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT06091865

Conditions

Diffuse Large B-cell Lymphoma (DLBCL)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Odronextamab

Rituximab

Cyclophosphamide

Doxorubicin

Vincristine

Study Details

Brief summary:

This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study.

This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study.

The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug when combined with chemotherapy
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
  • The impact from the study drug on quality of life and ability to complete routine daily activities

Conditions

Diffuse Large B-cell Lymphoma (DLBCL)

Study ID

NCT06091865

Start date

Dec 13, 2023

Status verified date

Aug, 2026

Completion date

Sep 12, 2029

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only)
2. Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2
4. Life expectancy ≥ 12 months
5. International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only
6. Adequate hematologic and organ function, as defined in the protocol.

Key Exclusion Criteria:

1. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology
2. Another active malignancy, significant active disease or medical condition, as described in the protocol
3. Peripheral neuropathy Grade ≥3
4. Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed/Refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic anti-lymphoma therapy.
5. Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment
6. Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
7. Allergy/hypersensitivity to study drugs, as described in the protocol
8. Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus Disease (COVID-19) infection, uncontrolled infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Study Design

Enrollment

904 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Odronextamab + CHOP

Part 1, includes dose escalation (Part 1A), and randomized exploration of 2 regimens of odronextamab -cyclophosphamide, doxorubicin, vincristine, prednisone (Odro-CHOP) dose optimization (Part 1B).

active comparator: Rituximab + CHOP

Part 2 is the randomized controlled portion, participants will receive either Odro-CHOP or R-CHOP.

Interventions

Odronextamab

Odronextamab will be administered by intravenous (IV) infusion

Rituximab

Rituximab will be administered IV, or subcutaneously (SC)

Cyclophosphamide

Cyclophosphamide will be administered IV as part of chemotherapy

Doxorubicin

Doxorubicin will be administered IV as part of chemotherapy

Vincristine

Vincristine will be administered IV as part of chemotherapy

Prednisone/Prednisolone

Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy

Primary outcome measure

  • Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 35 days ]
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 2 years ]
  • Severity of TEAEs [ Time Frame: Up to 2 years ]
  • Progression Free Survival (PFS), assessed by Independent Central Review (ICR) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Mayo Clinic - Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

David Geffen School of Medicine at UCLA

Recruiting

Los Angeles, California, United States, 90095

University of California Irvine Medical Center

Recruiting

Orange, California, United States, 92868

University of California (UC) Davis

Recruiting

Sacramento, California, United States, 95817

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

St Vincent Ascension at Peyton Manning Childrens Hospital

Recruiting

Indianapolis, Indiana, United States, 46260

Investigative Clinical Research of Indiana

Recruiting

Noblesville, Indiana, United States, 46062

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

University of Maryland Greenebaum Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Cancer and Hematology Centers of Western Michigan

Recruiting

Grand Rapids, Michigan, United States, 49503

Mayo Clinic - Rochester

Recruiting

Rochester, Minnesota, United States, 55901

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Community Cancer Trials of Utah

Recruiting

Ogden, Utah, United States, 84405

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Non-Hodgkin Lymphomas (NHL)
  • B-cell Non-Hodgkin Lymphomas (B-NHL)
  • Diffuse Large B-cell Lymphoma
  • Odronextamab
  • Anti-CD20 × anti-CD3 bispecific antibody

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-20.