Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo shows promise for Tough-to-Treat lymphoma

NCT ID NCT02651662

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-stage study tested two experimental drugs, odronextamab and cemiplimab, in 105 patients with aggressive B-cell lymphoma that had stopped responding to other treatments. The main goal was to check safety and find the best dose. Researchers also looked at how well the drugs worked and how the body processed them.

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

105 people

The number who actually took part.

Started

Jan 2016

Finished

Apr 2026

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+ aggressive B-cell NHL that is either not responsive to or relapsed after at least 2 prior lines of systemic therapy, for whom treatment with an anti-CD20 antibody may be appropriate. In addition, prior treatments should at least contain an anti-CD20 antibody and an alkylating agent. 2. Must have at least 1 nodal lesion (≥1.5 cm), or at least one extranodal lesion with longest transverse diameter (LDi) greater than 1.0 cm, documented by diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]). 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 4. Adequate bone marrow and hepatic function, as defined in the protocol 5. Willing and able to comply with clinic visits and study-related procedures 6. Provide signed informed consent 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, as described in the protocol 3. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (iAEs) 4. Prior therapies, as described in the protocol 5. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or other uncontrolled infection 6. Cytomegalovirus infection as noted by detectable levels on peripheral blood polymerase chain reaction (PCR) assay until the infection is well controlled. 7. Known hypersensitivity to both allopurinol and rasburicase 8. Pregnant or breastfeeding women 9. Women of childbearing potential, or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose, as defined in the protocol 10. Patients prior diagnosis of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS) Note: Other protocol-defined Inclusion/Exclusion criteria apply

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Relapsed/refractory aggressive B-cell lymphoma are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

aggressive B-cell non-Hodgkin lymphoma B-cell neoplasm Recurrence relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

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

Relapsed/refractory aggressive B-cell lymphoma

Contacts and locations

Locations

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49546, United States

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601, Israel

  • Copernicus Memorial Hospital

    Lodz, 93-513, Poland

  • Dana Farber/Harvard Cancer Center - PO box 849168

    Boston, Massachusetts, 02215, United States

  • Hadassah Medical Center

    Jerusalem, 91200, Israel

  • Harvard Medical School - Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008.0, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Institut Catala dOncologia (ICO Hospitalet)

    Barcelona, 08908, Spain

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • MD Anderson Cancer Center- Madrid

    Madrid, 28033, Spain

  • Medical University Vienna

    Vienna, 1190, Austria

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa

    Warsaw, 02781, Poland

  • Pratia MCM Krakow

    Krakow, Malopolska, 30-510, Poland

  • Pratia Onkologia Katowice

    Katowice, 40-519, Poland

  • Soroka

    Beersheba, 84101, Israel

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III

    Salzburg, 5020, Austria

  • Universitatsklinikum Jena

    Jena, 7747, Germany

  • Universitatsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105, Germany

  • University Hospital Frankfurt

    Frankfurt am Main, 60590, Germany

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

More trials for these conditions

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