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B-cell Non-Hodgkin Lymphoma (B-NHL)Phase 2ELM-2NCT03888105

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies

A Phase 2 study testing Odronextamab in people with B-cell Non-Hodgkin Lymphoma (B-NHL), run by Regeneron Pharmaceuticals at 119 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is researching an investigational drug, odronextamab, in adult patients B-cell non-Hodgkin's lymphoma (B-NHL). The main purpose of this study is to assess the effectiveness of odronextamab in destroying cancer cells and to learn more about the safety of odronextamab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Non-Hodgkin Lymphoma (B-NHL)
What is being tested?
Odronextamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
515 participants
Where
119 sitesin 14 countries
Study dates
13 Nov 2019to 15 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • 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
Show all 11Show fewer
  • 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.
  • Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate bone marrow, hepatic, and renal function as defined in the protocol

Who cannot join

  • 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)
  • 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
  • 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
  • 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
  • History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded
  • 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
Show all 10Show fewer
  • 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
  • Known hypersensitivity to both allopurinol and rasburicase
  • Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
  • Note: Other protocol-defined Inclusion/Exclusion criteria apply

Trial locations and contacts

119 sites in 14 countries.

119 sites in 14 countries

China17 sites

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

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Peking University - Third Hospital

    Beijing, 100191

  • The First Bethune Hospital

    Changchun, Jilin, 130021

  • West China Hospital

    Chengdu, Sichuan, 610041

  • Second Affiliated Hospital - Xinqiao Hospital

    Chongqing, Chongqing Municipality, 400000

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

    Guangzhou, Guangdong, 510000

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

    Hangzhou, Zhejiang, 310003

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • The Affiliated Tumor Hospital

    Harbin, Heilongjiang, 150081

  • Shanhai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • The First Affiliated Hospital - Soochow University

    Suzhou, Jiangsu, 215000

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Beijing Municipality, 300020

  • Tianjin Medical University Cancer Institute

    Tianjin, Tianjin Municipality, 300060

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

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

Other trials in China

Japan14 sites

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

  • National Cancer Center Hospital - Tsukiji Campus

    Chuo Ku, Tokyo, 104-0045

  • National Hospital Organization National Kyushu Cancer Center

    Fukuoka, Hukuoka, 811-1395

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1298

  • Tokai University Hospital

    Isehara-Shi, Kanagawa, 259-1193

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, 852-8511

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

    Nagoya, Aichi-ken, 466-8650

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aiti, 460-0001

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585

Other trials in Japan

United States13 sites

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Harold C. Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390

  • John Theurer Cancer Center at Hackensack UMC

    Hackensack, New Jersey, 07601

  • University of Iowa

    Iowa City, Iowa, 52242

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Weill Cornell Medical College New York Presbyterian Hospital

    New York, New York, 10021

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27257

Other trials in United States

Spain12 sites

  • Ico Lhospitalet - Hospital Duran i Reynals

    Barcelona, Catalonia, 8907

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona - Planta 4 Escalera

    Barcelona, 8036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitari Son Espases

    Palma, Balearic Islands, 07120

  • Hospital Son Llatzer

    Palma, Balearic Islands, 07198

  • Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Italy10 sites

  • University of Bologna Dipartimento di Medicina Specialistica Diagnostica e Sperimentale

    Bologna, 40138

  • Uos Ematologia - Ospedale Civile di Livorno

    Livorno, 57124

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

    Milan, Milan, 20122

  • ASST Grande Ospedale Metropolitano Niguarda - Division of Hematology

    Milan, 20162

  • AOU Maggiore della Carita

    Novara, 28100

  • Presidio Ospedaliero Santa Maria della Misericordia

    Perugia, 6156

  • Ospedale Santa Maria delle Croci

    Ravenna, 48121

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123

  • Ospedale dell'Angelo - Varese

    Varese, 21100

  • Ospedale DellAngelo Di Mestre

    Venice, 30174

Other trials in Italy

France9 sites

  • Centre Hospitalier Universitaire de Caen - Hematologie Clinique IHBN

    Caen, Calvados, 14000

  • Unite Hemopathies Lymphoides Hospital Henri Mondor

    Créteil, Île-de-France Region, 94010

  • Hopital Claude Huriez - CHR Lille

    Lille, Nord, 59037

  • CHU Hotel Dieu Service Hematologie

    Nantes, Pays de la Loire Region, 44093

  • Hopital Saint Louis

    Paris, 75010

  • Hospital de la Pitie-Salpetriere

    Paris, 75651

  • Hopital Haut-Leveque

    Pessac, Aquitaine, 33604

  • Hopital Lyon Sud

    Pierre-Bénite, Lyon, 69310

  • Chu Poitiers - Pole Regional De Cancerologie

    Poitiers, Vienne, 86000

Other trials in France

Poland8 sites

  • Uniwersyteckie Centrum

    Gdansk, Pomeranian Voivodeship, 80-214

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

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

    Gdynia, Pomeranian Voivodeship, 81519

  • Szpitale Pomorskie spSp. Z.o.o.

    Gdynia, 81-519

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

    Lodz, 93-513

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

    Warsaw, Masovian Voivodeship, 02-781

  • Instytut Hematologii I Transfuzjologii Klinika Hematologii

    Warsaw, 02-776

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

    Wroclaw, 50-367

Other trials in Poland

South Korea8 sites

  • Dong-A University Hospital

    Busan, 49201

  • National Cancer Center

    Gyeonggi-do, Gyeonggi-do, 10408

  • Seoul National University Hospital

    Seoul, 3080

  • Severance Hospital

    Seoul, 3722

  • Samsung Medical Center

    Seoul, 6351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 6591

  • Ewha Womans University Mokdong Hospital - Hemato Oncology

    Seoul, 7985

  • University of Ulsan College of Medicine

    Ulsan, Daegu, 682-714

Other trials in South Korea

Taiwan8 sites

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung City, 83301

  • China Medical University

    Taichung, 40447

  • National Cheng Kung University

    Tainan, 704

  • Chi-Mei Medical Center - Liuying

    Tainan, 736

  • National Taiwan University Hospital

    Taipei, 10002

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 11251

  • Tri-Service General Hospital

    Taipei, 11490

  • Chang Gung Medical Foundation-

    Taoyuan, 333

Other trials in Taiwan

Australia7 sites

  • Border Medical Oncology

    East Albury, New South Wales, 2640

  • Epworth Hospital

    East Melbourne, Victoria, VIC 3002

  • North Building

    Frankston, Victoria, 3199

  • Andrew Love Cancer Centre

    Geelong, Victoria, 3220

  • Olivia Newton John Cancer Wellness & Research Centre

    Heidelberg, Victoria, VIC 3084

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Northern NSW Local Health District The Tweed Hospital

    Tweed Heads, South Wales, 2485

Other trials in Australia

United Kingdom5 sites

  • University Hospital of Wales

    Cardiff, Wales, CF14 4XW

  • Kings College Hospital

    London, SE5 9RS

  • Derriford Hospital and the Royal Eye Infirmary

    Plymouth, Devon, PL6 8DH

  • The Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Germany3 sites

  • University Hospital Halle Saale

    Halle, 6120

  • Kliniken Ostalb Stauferklinikum Schwab Gmund

    Mutlangen, Gmund, D-73557

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

    Würzburg, 97080

Other trials in Germany

Singapore3 sites

  • National University Hospital

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 169608

  • Icon Soc Farrer Park

    Singapore, 217562

Other trials in Singapore

Canada2 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G172

  • QEII Health Science Centre - Halifax location

    Halifax, Nova Scotia, B3H 2Y9

Other trials in Canada

About this study

Official title: An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

This study is researching an investigational drug, odronextamab, in adult patients B-cell non-Hodgkin's lymphoma (B-NHL).

The main purpose of this study is to assess the effectiveness of odronextamab in destroying cancer cells and to learn more about the safety of odronextamab.

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

  • To see if odronextamab works to destroy cancer cells
  • Side effects that may be experienced by people taking odronextamab
  • How odronextamab works in the body
  • How much odronextamab is present in the blood
Being tested
Odronextamab
Keywords
Relapsed B-NHL, Refractory B-NHL, NHL, Follicular lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL), Mantle cell lymphoma (MCL), Marginal zone lymphoma (MZL), bispecific antibody, CD20
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OdronextamabDrug

    Also called REGN1979

    Administered by intravenous (IV) infusion

Study groups in NCT03888105
Study groupRoleWhat they receive
FLExperimentalFollicular lymphoma grade 1-3a cohort
Receives: Drug: Odronextamab
DLBCLExperimentalDiffuse large B-cell lymphoma cohort
Receives: Drug: Odronextamab
MCLExperimentalMantle Cell Lymphoma cohort
Receives: Drug: Odronextamab
MZLExperimentalMarginal Zone Lymphoma cohort
Receives: Drug: Odronextamab
Other B-NHLExperimentalOther B-cell non-Hodgkin lymphoma cohort (excluding FL Grade 1-3a, DLBCL, MCL, MZL, Waldenström macroglobulinemia [WM]); Patients with a current diagnosis of mixed histology of B-NHL with an aggressive component (such as concurrent FL and DLBCL) will be allowed
Receives: Drug: Odronextamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR), as assessed by independent central review

    FL grade 1-3a/MZL

    Measured: Up to 52 weeks of study treatment

  2. ORR, as assessed by independent central review

    DLBCL/MCL/Other B-NHL

    Measured: Up to 36 weeks of study treatment

Secondary outcomes (23)

  1. ORR, as assessed by the local investigator

    FL/MZL

    Measured: Up to 52 weeks of study treatment

  2. ORR, as assessed by the local investigator

    DLBCL/MCL/Other B-NHL

    Measured: Up to 36 weeks of study treatment

  3. Complete Response (CR) Rate, as assessed by the local investigator

    FL grade 1-3a/MZL

    Measured: Up to 52 weeks of study treatment

  4. CR rate, as assessed by independent central review

    FL grade 1-3a/MZL

    Measured: Up to 52 weeks of study treatment

  5. CR rate, as assessed by the local investigator

    DLBCL/MCL/Other B-NHL

    Measured: Up to 36 weeks of study treatment

  6. CR rate, as assessed by independent central review

    DLBCL/MCL/Other B-NHL

    Measured: Up to 36 weeks of study treatment

  7. Progression-Free Survival (PFS), as assessed by independent central review

    Measured: Approximately 194 weeks following the first dose

  8. PFS, as assessed by the local investigator

    Measured: Approximately 194 weeks following the first dose

  9. Overall Survival (OS)

    Measured: Approximately 194 weeks following the first dose

  10. Duration Of Response (DOR), as assessed by independent central review

    Measured: Approximately 194 weeks following the first dose

  11. DOR, as assessed by the local investigator

    Measured: Approximately 194 weeks following the first dose

  12. Disease Control Rate (DCR), as assessed by independent central review

    FL grade 1-3a/MZL

    Measured: Up to 52 weeks of study treatment

  13. DCR, as assessed by the local investigator

    FL grade 1-3a/MZL

    Measured: Up to 52 weeks of study treatment

  14. DCR, as assessed by independent central review

    DLBCL/MCL/Other B-NHL

    Measured: Up to 36 weeks of study treatment

  15. DCR, as assessed by the local investigator

    DLBCL/MCL/Other B-NHL

    Measured: Up to 36 weeks of study treatment

  16. Incidence and severity of Treatment Emergent Adverse Events (TEAEs)

    Measured: Approximately 194 weeks following the first dose

  17. Concentration of odronextamab

    End of infusion [EOI]; Concentration at a specified time t [Ct])

    Measured: 12 weeks following end of treatment

  18. Incidence of Anti-Drug Antibodies (ADA) to odronextamab over time

    Measured: 12 weeks following end of treatment

  19. Titer of anti-drug antibodies to odronextamab over time

    Measured: 12 weeks following end of treatment

  20. Incidence of Neutralizing antibodies (Nab) to odronextamab over time

    Measured: 12 weeks following end of treatment

  21. Changes in scores of patient-reported outcomes as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC-QLQ-C30)

    The EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).

    Measured: Approximately 194 weeks following the first dose

  22. Changes in scores of patient-reported outcomes as measured by Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym)

    Composed of the FACT-G plus the 15-item Lymphoma Subscale (LymS).

    Measured: Approximately 194 weeks following the first dose

  23. Changes in scores of patient-reported outcomes as measured by EuroQol-5 Dimensions-3 Levels (EQ-5D-3L)

    The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.

    Measured: Approximately 194 weeks following the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2019
  2. Study start13 Nov 2019
  3. Primary completion17 Jun 2026
  4. Study completion15 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
5 cohorts The first 68 patients in the DLBCL cohort will be randomized; the remaining patients will not be randomized
Masking
None (open label)
Enrolment
515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03888105
Sponsor's protocol ID
R1979-ONC-1625
Other IDs
2017-002139-41, 2024-511747-25-00, 2017
Acronym
ELM-2
Status last verified
Jul 2026
First submitted
14 Mar 2019
Last updated
31 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Publications

  • Villasboas JC, Poon M, Tani M, Jimenez-Ubieto A, Tessoulin B, Warwick L, Brown D, Namuduri M, Lin C, Delwart V, Jagadeesh D. Odronextamab in people with relapsed or refractory follicular lymphoma: plain language summary of the ELM-2 study. Future Oncol. 2026 Mar;22(6):643-658. doi: 10.1080/14796694.2026.2628111. Epub 2026 Mar 1.

    PubMed 41766170

  • Arnason JE, Matasar M, Luminari S, Tucker D, Sun D, Tao W, Zhu YO, Kundu K, Gupta NT, Leary A, Jankovic V, Ambati S, Mohamed H, Chaudhry A, Brouwer-Visser J. Early clearance of circulating tumor DNA and association with odronextamab response in relapsed/refractory FL and DLBCL. Blood Adv. 2025 Dec 9;9(23):6130-6140. doi: 10.1182/bloodadvances.2025016332.

    PubMed 40902079

  • Danilov AV, Kambhampati Thiruvengadam S, Linton K, Cumings K, Chirikov V, Mutebi A, Bains Chawla S, Chhibber A, Rivas Navarro F, Marques Goncalves F, Wang A, Ding Z, Alshreef A, Favaro E, Hoehn D, Sureda A. Indirect comparison of epcoritamab vs chemoimmunotherapy, mosunetuzumab, or odronextamab in follicular lymphoma. Blood Adv. 2025 Aug 12;9(15):3754-3765. doi: 10.1182/bloodadvances.2024015274.

    PubMed 40472301

  • Kim WS, Kim TM, Cho SG, Jarque I, Iskierka-Jazdzewska E, Poon LM, Prince HM, Zhang H, Cao J, Zhang M, Tessoulin B, Oh SY, Lim F, Carpio C, Tan TD, Ayyappan S, Gutierrez A, Cai J, Ufkin M, Shariff S, Brouwer-Visser J, Chaudhry A, Mohamed H, Ambati S, Walewski J; ELM-2 Investigators. Odronextamab monotherapy in patients with relapsed/refractory diffuse large B cell lymphoma: primary efficacy and safety analysis in phase 2 ELM-2 trial. Nat Cancer. 2025 Mar;6(3):528-539. doi: 10.1038/s43018-025-00921-6. Epub 2025 Mar 17.

    PubMed 40097657

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Odronextamab in people with B-cell Non-Hodgkin Lymphoma (B-NHL), run by Regeneron Pharmaceuticals at 119 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in China, Japan, United States, Spain, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR), as assessed by independent central review (time frame: Up to 52 weeks of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03888105, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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