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New antibody drug shows promise against Hard-to-Treat lymphoma

NCT ID NCT03888105

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This Phase 2 trial tests an investigational drug called odronextamab in 515 adults with B-cell non-Hodgkin lymphoma that has come back or not responded to treatment. The drug is designed to help the immune system attack cancer cells. The main goal is to see if it shrinks tumors and to check for side effects.

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 helps immune cells attack cancer cells)
What this could lead to
If successful, this could offer a new treatment option for people with B-cell non-Hodgkin lymphoma who have not responded to other therapies.
What could go wrong
This is a Phase 2 trial, so it is still early. The drug may not work for everyone, and side effects could be serious. Results may not lead to approval.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

515 people

The number who actually took part.

Started

Nov 2019

Expected to finish

Dec 2028

An estimate. End dates often move.

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. For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017) 2. Disease-specific cohorts: Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment * FL grade 1-3a cohort: Patients with FL grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, as defined in the protocol * DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol * MCL after BTK inhibitor therapy cohort: Patients with MCL who have relapsed or refractory disease to at least one prior line of systemic therapy and had prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor * MZL cohort: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy * Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma. 3. Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI) 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Adequate bone marrow, hepatic, and renal function as defined in the protocol Key Exclusion Criteria: 1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI) 2. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter 3. History of allogeneic stem cell transplantation, up to 12 months prior to first administration of study drug. The presence of acute or chronic graft-versus host disease (GVHD) will also be an exclusion 4. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug 5. History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded 6. Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent 7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections 8. Known hypersensitivity to both allopurinol and rasburicase 9. Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy Note: Other protocol-defined Inclusion/Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm B-cell non-Hodgkin lymphoma diffuse large B-cell lymphoma follicular lymphoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma

As listed by the trial registrant

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

B-cell non-Hodgkin lymphoma (B-NHL)

Contacts and locations

Locations

  • AOU Maggiore della Carita

    Novara, 28100, Italy

  • ASST Grande Ospedale Metropolitano Niguarda - Division of Hematology

    Milan, 20162, Italy

  • Andrew Love Cancer Centre

    Geelong, Victoria, 3220, Australia

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123, Italy

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Border Medical Oncology

    East Albury, New South Wales, 2640, Australia

  • CHU Hotel Dieu Service Hematologie

    Nantes, Pays de la Loire Region, 44093, France

  • Centre Hospitalier Universitaire de Caen - Hematologie Clinique IHBN

    Caen, Calvados, 14000, France

  • Centrum Onkologii Instytut im M Sklodowskiej CurieOddzial Chorob United Kingdomladu Chlonnego

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Chang Gung Medical Foundation-

    Taoyuan, 333, Taiwan

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung City, 83301, Taiwan

  • Chi-Mei Medical Center - Liuying

    Tainan, 736, Taiwan

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717, Japan

  • China Medical University

    Taichung, 40447, Taiwan

  • Chu Poitiers - Pole Regional De Cancerologie

    Poitiers, Vienne, 86000, France

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G172, Canada

  • Derriford Hospital and the Royal Eye Infirmary

    Plymouth, Devon, PL6 8DH, United Kingdom

  • Dong-A University Hospital

    Busan, 49201, South Korea

  • Epworth Hospital

    East Melbourne, Victoria, VIC 3002, Australia

  • Ewha Womans University Mokdong Hospital - Hemato Oncology

    Seoul, 7985, South Korea

  • Harold C. Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390, United States

  • Hopital Claude Huriez - CHR Lille

    Lille, Nord, 59037, France

  • Hopital Haut-Leveque

    Pessac, Aquitaine, 33604, France

  • Hopital Lyon Sud

    Pierre-Bénite, Lyon, 69310, France

  • Hopital Saint Louis

    Paris, 75010, France

  • Hospital Clinic de Barcelona - Planta 4 Escalera

    Barcelona, 8036, Spain

  • Hospital Son Llatzer

    Palma, Balearic Islands, 07198, Spain

  • Hospital Universitari Son Espases

    Palma, Balearic Islands, 07120, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital de la Pitie-Salpetriere

    Paris, 75651, France

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041, Spain

  • Ico Lhospitalet - Hospital Duran i Reynals

    Barcelona, Catalonia, 8907, Spain

  • Icon Soc Farrer Park

    Singapore, 217562, Singapore

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Beijing Municipality, 300020, China

  • Instytut Hematologii I Transfuzjologii Klinika Hematologii

    Warsaw, 02-776, Poland

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

    Nagoya, Aichi-ken, 466-8650, Japan

  • Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, 852-8511, Japan

  • John Theurer Cancer Center at Hackensack UMC

    Hackensack, New Jersey, 07601, United States

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Kliniken Ostalb Stauferklinikum Schwab Gmund

    Mutlangen, Gmund, D-73557, Germany

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 11251, Taiwan

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • National Cancer Center

    Gyeonggi-do, Gyeonggi-do, 10408, South Korea

  • National Cancer Center Hospital - Tsukiji Campus

    Chuo Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University

    Tainan, 704, Taiwan

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aiti, 460-0001, Japan

  • National Hospital Organization National Kyushu Cancer Center

    Fukuoka, Hukuoka, 811-1395, Japan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National University Hospital

    Singapore, 119074, Singapore

  • North Building

    Frankston, Victoria, 3199, Australia

  • Northern NSW Local Health District The Tweed Hospital

    Tweed Heads, South Wales, 2485, Australia

  • Norton Cancer Institute

    Louisville, Kentucky, 40207, United States

  • Olivia Newton John Cancer Wellness & Research Centre

    Heidelberg, Victoria, VIC 3084, Australia

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586, Japan

  • Ospedale DellAngelo Di Mestre

    Venice, 30174, Italy

  • Ospedale Santa Maria delle Croci

    Ravenna, 48121, Italy

  • Ospedale dell'Angelo - Varese

    Varese, 21100, Italy

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Peking University - Third Hospital

    Beijing, 100191, China

  • Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research)

    Beijing, Beijing Municipality, 100142, China

  • Pomorskie Hospitals SP. Z O. O. Oncology And Radiotherapy Ward

    Gdynia, Pomeranian Voivodeship, 81519, Poland

  • Presidio Ospedaliero Santa Maria della Misericordia

    Perugia, 6156, Italy

  • QEII Health Science Centre - Halifax location

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ, United Kingdom

  • Royal Perth Hospital

    Perth, Western Australia, 6000, Australia

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1298, Japan

  • Samsung Medical Center

    Seoul, 6351, South Korea

  • Second Affiliated Hospital - Xinqiao Hospital

    Chongqing, Chongqing Municipality, 400000, China

  • Seoul National University Hospital

    Seoul, 3080, South Korea

  • Severance Hospital

    Seoul, 3722, South Korea

  • Shanhai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Singapore General Hospital

    Singapore, 169608, Singapore

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • Sun Yat-Sen University Cancer Center - Cancer Prevention and Treatment Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510000, China

  • Szpitale Pomorskie spSp. Z.o.o.

    Gdynia, 81-519, Poland

  • The Affiliated Tumor Hospital

    Harbin, Heilongjiang, 150081, China

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 6591, South Korea

  • The First Affiliated Hospital - Soochow University

    Suzhou, Jiangsu, 215000, China

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000, China

  • The First Bethune Hospital

    Changchun, Jilin, 130021, China

  • The First Hospital affiliated to the Medical School of Zhejiang University

    Hangzhou, Zhejiang, 310003, China

  • The Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT, United Kingdom

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

  • Tianjin Medical University Cancer Institute

    Tianjin, Tianjin Municipality, 300060, China

  • Tokai University Hospital

    Isehara-Shi, Kanagawa, 259-1193, Japan

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

  • Tri-Service General Hospital

    Taipei, 11490, Taiwan

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UOC Hematologia, Fondazione IRCCS, Ca Granda, OM Policlinico

    Milan, Milan, 20122, Italy

  • Unite Hemopathies Lymphoides Hospital Henri Mondor

    Créteil, Île-de-France Region, 94010, France

  • Universitatsklinik Wurzburg, Med Klinik und Poliklinik II, Zentrum Innere Medizin

    Würzburg, 97080, Germany

  • University Hospital Halle Saale

    Halle, 6120, Germany

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566, Japan

  • University Hospital of Wales

    Cardiff, Wales, CF14 4XW, United Kingdom

  • University of Bologna Dipartimento di Medicina Specialistica Diagnostica e Sperimentale

    Bologna, 40138, Italy

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Ulsan College of Medicine

    Ulsan, Daegu, 682-714, South Korea

  • Uniwersytecki Szpital Kliniczny we Wroclawiu, Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych

    Wroclaw, 50-367, Poland

  • Uniwersyteckie Centrum

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214, Poland

  • Uos Ematologia - Ospedale Civile di Livorno

    Livorno, 57124, Italy

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27257, United States

  • Weill Cornell Medical College New York Presbyterian Hospital

    New York, New York, 10021, United States

  • West China Hospital

    Chengdu, Sichuan, 610041, China

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)

    Lodz, 93-513, Poland

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585, Japan

More trials for these conditions

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