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
ELM-2
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
3 other identifiers
interventional
515
14 countries
119
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2019
Longer than P75 for phase_2
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedStudy Start
First participant enrolled
November 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 15, 2028
October 15, 2025
October 1, 2025
6.6 years
March 14, 2019
October 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Objective Response Rate (ORR), as assessed by independent central review
FL grade 1-3a/MZL
Up to 52 weeks of study treatment
ORR, as assessed by independent central review
DLBCL/MCL/Other B-NHL
Up to 36 weeks of study treatment
Secondary Outcomes (23)
ORR, as assessed by the local investigator
Up to 52 weeks of study treatment
ORR, as assessed by the local investigator
Up to 36 weeks of study treatment
Complete Response (CR) Rate, as assessed by the local investigator
Up to 52 weeks of study treatment
CR rate, as assessed by independent central review
Up to 52 weeks of study treatment
CR rate, as assessed by the local investigator
Up to 36 weeks of study treatment
- +18 more secondary outcomes
Study Arms (5)
FL
EXPERIMENTALFollicular lymphoma grade 1-3a cohort
DLBCL
EXPERIMENTALDiffuse large B-cell lymphoma cohort
MCL
EXPERIMENTALMantle Cell Lymphoma cohort
MZL
EXPERIMENTALMarginal Zone Lymphoma cohort
Other B-NHL
EXPERIMENTALOther 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
Interventions
Administered by intravenous (IV) infusion
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (119)
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, 07601, United States
Weill Cornell Medical College New York Presbyterian Hospital
New York, New York, 10021, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27257, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, 75390, United States
Border Medical Oncology
East Albury, New South Wales, 2640, Australia
Northern NSW Local Health District The Tweed Hospital
Tweed Heads, South Wales, 2485, Australia
Epworth Hospital
East Melbourne, Victoria, VIC 3002, Australia
North Building
Frankston, Victoria, 3199, Australia
Andrew Love Cancer Centre
Geelong, Victoria, 3220, Australia
Olivia Newton John Cancer Wellness & Research Centre
Heidelberg, Victoria, VIC 3084, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Cross Cancer Institute
Edmonton, Alberta, T6G172, Canada
QEII Health Science Centre - Halifax location
Halifax, Nova Scotia, B3H 2Y9, Canada
Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research)
Beijing, Beijing Municipality, 100142, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Institute of Hematology & Blood Diseases Hospital
Tianjin, Beijing Municipality, 300020, China
Second Affiliated Hospital - Xinqiao Hospital
Chongqing, Chongqing Municipality, 400000, China
Sun Yat-Sen University Cancer Center - Cancer Prevention and Treatment Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
The Affiliated Tumor Hospital
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
The First Affiliated Hospital - Soochow University
Suzhou, Jiangsu, 215000, China
The First Bethune Hospital
Changchun, Jilin, 130021, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Shanhai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
West China Hospital
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute
Tianjin, Tianjin Municipality, 300060, China
The First Hospital affiliated to the Medical School of Zhejiang University
Hangzhou, Zhejiang, 310003, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Peking University - Third Hospital
Beijing, 100191, China
Hopital Haut-Leveque
Pessac, Aquitaine, 33604, France
Centre Hospitalier Universitaire de Caen - Hematologie Clinique IHBN
Caen, Calvados, 14000, France
Hopital Lyon Sud
Pierre-Bénite, Lyon, 69310, France
Hopital Claude Huriez - CHR Lille
Lille, Nord, 59037, France
CHU Hotel Dieu Service Hematologie
Nantes, Pays de la Loire Region, 44093, France
Chu Poitiers - Pole Regional De Cancerologie
Poitiers, Vienne, 86000, France
Hopital Saint Louis
Paris, 75010, France
Hospital de la Pitie-Salpetriere
Paris, 75651, France
Unite Hemopathies Lymphoides Hospital Henri Mondor
Créteil, Île-de-France Region, 94010, France
Kliniken Ostalb Stauferklinikum Schwab Gmund
Mutlangen, Gmund, D-73557, Germany
University Hospital Halle Saale
Halle, 6120, Germany
Universitatsklinik Wurzburg, Med Klinik und Poliklinik II, Zentrum Innere Medizin
Würzburg, 97080, Germany
UOC Hematologia, Fondazione IRCCS, Ca Granda, OM Policlinico
Milan, Milan, 20122, Italy
University of Bologna Dipartimento di Medicina Specialistica Diagnostica e Sperimentale
Bologna, 40138, Italy
Uos Ematologia - Ospedale Civile di Livorno
Livorno, 57124, Italy
ASST Grande Ospedale Metropolitano Niguarda - Division of Hematology
Milan, 20162, Italy
AOU Maggiore della Carita
Novara, 28100, Italy
Presidio Ospedaliero Santa Maria della Misericordia
Perugia, 6156, Italy
Ospedale Santa Maria delle Croci
Ravenna, 48121, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, 42123, Italy
Ospedale dell'Angelo - Varese
Varese, 21100, Italy
Ospedale DellAngelo Di Mestre
Venice, 30174, Italy
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650, Japan
National Hospital Organization Nagoya Medical Center
Nagoya, Aiti, 460-0001, Japan
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
National Hospital Organization National Kyushu Cancer Center
Fukuoka, Hukuoka, 811-1395, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Tokai University Hospital
Isehara-Shi, Kanagawa, 259-1193, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298, Japan
National Cancer Center Hospital - Tsukiji Campus
Chuo Ku, Tokyo, 104-0045, Japan
Yamagata University Hospital
Yamagata, Yamagata, 990-9585, Japan
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, 852-8511, Japan
Centrum Onkologii Instytut im M Sklodowskiej CurieOddzial Chorob United Kingdomladu Chlonnego
Warsaw, Masovian Voivodeship, 02-781, Poland
Uniwersyteckie Centrum
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Pomorskie Hospitals SP. Z O. O. Oncology And Radiotherapy Ward
Gdynia, Pomeranian Voivodeship, 81519, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Szpitale Pomorskie spSp. Z.o.o.
Gdynia, 81-519, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)
Lodz, 93-513, Poland
Instytut Hematologii I Transfuzjologii Klinika Hematologii
Warsaw, 02-776, Poland
Uniwersytecki Szpital Kliniczny we Wroclawiu, Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych
Wroclaw, 50-367, Poland
National University Hospital
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Icon Soc Farrer Park
Singapore, 217562, Singapore
University of Ulsan College of Medicine
Ulsan, Daegu, 682-714, South Korea
National Cancer Center
Gyeonggi-do, Gyeonggi-do, 10408, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Severance Hospital
Seoul, 3722, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 6591, South Korea
Ewha Womans University Mokdong Hospital - Hemato Oncology
Seoul, 7985, South Korea
Hospital Universitari Son Espases
Palma, Balearic Islands, 07120, Spain
Hospital Son Llatzer
Palma, Balearic Islands, 07198, Spain
Ico Lhospitalet - Hospital Duran i Reynals
Barcelona, Catalonia, 8907, Spain
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona - Planta 4 Escalera
Barcelona, 8036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 8041, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, 83301, Taiwan
China Medical University
Taichung, 40447, Taiwan
National Cheng Kung University
Tainan, 704, Taiwan
Chi-Mei Medical Center - Liuying
Tainan, 736, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 11251, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Chang Gung Medical Foundation-
Taoyuan District, 333, Taiwan
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ, United Kingdom
Derriford Hospital and the Royal Eye Infirmary
Plymouth, Devon, PL6 8DH, United Kingdom
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
University Hospital of Wales
Cardiff, Wales, CF14 4XW, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
Related Publications (3)
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.
PMID: 40902079DERIVEDDanilov 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.
PMID: 40472301DERIVEDKim 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.
PMID: 40097657DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2019
First Posted
March 25, 2019
Study Start
November 13, 2019
Primary Completion (Estimated)
July 6, 2026
Study Completion (Estimated)
December 15, 2028
Last Updated
October 15, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
- Access Criteria
- Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing