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New 'Bispecific' antibody takes aim at Hard-to-Treat blood cancers

NCT ID NCT02290951

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested a drug called odronextamab in 200 people with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia that had stopped responding to prior treatments. The drug is a bispecific antibody designed to bring immune cells close to cancer cells to kill them. The main goals were to check safety and find the right dose, while also looking at whether tumors shrank.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Odronextamab (a bispecific antibody that targets both CD20 on cancer cells and CD3 on immune cells)
What this could lead to
If successful, this could lead to a new treatment option for patients with B-cell cancers who have run out of standard therapies.
What could go wrong
This is an early Phase 1 trial focused on safety, so it is not yet proven to work. Side effects may occur, and the drug may not shrink tumors in most patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

200 people

The number who actually took part.

Started

Jan 2015

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Have documented CD20+ B-cell malignancy, with active disease not responsive to prior therapy, for whom no standard of care options exists, and for whom treatment with an anti-CD20 antibody may be appropriate: * Part A (IV administration) B-NHL confirmed by National Cancer Institute (NCI) working group criteria * Part B (SC administration): Confirmed diagnosis of B-NHL requiring therapy as defined by WHO classification 2017 2. Patients with B-NHL must have had prior treatment with an anti-CD20 antibody therapy. Patients with CLL (Part A only) are not required to have received prior treatment with an anti-CD20 antibody therapy as defined in the protocol. * For the inclusion in the disease-specific expansion cohort enrolling DLBCL patients after failure of CAR-T therapy, the patient must have recovered from the toxicities of the lymphodepletion therapy and CAR-T infusion. * For inclusion in Part B, patients must have FL grade 1-3a or DLBCL (with or without prior CAR-T) per the criteria above, and: * Patients with FL grade 1-3a and DLBCL must have received at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent 3. All patients must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT or MRI scan, if CT scan is not feasible. 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 5. Life expectancy of at least 6 months 6. Adequate bone marrow function as described in the protocol 7. Adequate organ function as described in the protocol 8. Willingness to undergo mandatory tumor biopsy pretreatment, if in the opinion of the investigator, the patient has an accessible lesion that can be biopsied without significant risk to the patient. 9. Willing and able to comply with clinic visits and study-related procedures 10. Provide signed informed consent or legally acceptable representative Key Exclusion Criteria: 1. Primary central nervous system (CNS) lymphoma or known or suspected CNS involvement by non-primary CNS NHL 2. History of or current relevant CNS pathology such as * Epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis, or * Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI 3. Standard anti-lymphoma chemotherapy (non-biologic) or radiotherapy within 28 days prior to first administration of study drug 4. Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) infection \[(as noted by detectable levels on a blood polymerase chain reaction (PCR) assay)\]. 1. Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus deoxyribonucleic acid (DNA) that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted upon consultation with the physician managing the infection. 2. Patients who show detectable levels of CMV at screening will need to be treated with appropriate antiviral therapy and demonstrate at least 2 undetectable levels of CMV by PCR assay (at least 7 days apart) before being re-considered for eligibility. 5. Patients who have received a live vaccination within 28 days of first dose of study treatment Note: Other protocol Inclusion/Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia B-cell non-Hodgkin lymphoma diffuse large B-cell lymphoma follicular lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukemia Non-Hodgkin lymphoma

Contacts and locations

Locations

  • Assuta Ashdod University Hospital

    Ashdod, Southern District, 7747629, Israel

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CHU Hôpital Lyon Sud

    Lyon, 69495, France

  • Centre Henri Becquerel

    Rouen, Haute-Normandie, 76038, France

  • Dana Farber Cancer Institute (Massachusetts General Hospital and Beth Israel)

    Boston, Massachusetts, 02215, United States

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001, Israel

  • Institut Gustave Roussy

    Villejuif, Île-de-France Region, 94800, France

  • Lady Davis Carmel Medical Center

    Haifa, 3436212, Israel

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Meir Medical Center

    Kfar Saba, Central District, 44281, Israel

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Rambam Health Care Campus - Hematology and Bone Marrow Transplantation Institute

    Haifa, 3109601, Israel

  • Royal Cornwall Hospitals NHS Trust

    Truro, Cornwall, tr1 3lq, United Kingdom

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • Stanford University

    Stanford, California, 94305, United States

  • The Chaim Sheba Medical Center

    Tel-Hashomer, Central District, 5265601, Israel

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • Universitatsklinikum Wurzburg

    Würzburg, Bavaria, 97080, Germany

  • University of California, Irvine

    Orange, California, 92868, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.