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

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

Study Overview

• Status: Active, not recruiting
• Conditions: B-cell Non-Hodgkin Lymphoma (B-NHL)
• Intervention / Treatment: Drug: Odronextamab

• Study Type: Interventional
• Enrollment (Actual): 515
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • East Albury, New South Wales, Australia, 2640
      • Border Medical Oncology
  • South Wales
    • Tweed Heads, South Wales, Australia, 2485
      • Northern NSW Local Health District The Tweed Hospital
  • Victoria
    • East Melbourne, Victoria, Australia, VIC 3002
      • Epworth Hospital
    • Frankston, Victoria, Australia, 3199
      • North Building
    • Geelong, Victoria, Australia, 3220
      • Andrew Love Cancer Centre
    • Heidelberg, Victoria, Australia, VIC 3084
      • Olivia Newton John Cancer Wellness & Research Centre
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Royal Perth Hospital
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G172
      • Cross Cancer Institute
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • QEII Health Science Centre - Halifax location
• China
  • Beijing, China, 100191
    • Peking University - Third Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital
    • Beijing, Beijing Municipality, China, 100142
      • Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research)
    • Tianjin, Beijing Municipality, China, 300020
      • Institute of Hematology & Blood Diseases Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400000
      • Second Affiliated Hospital - Xinqiao Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-Sen University Cancer Center - Cancer Prevention and Treatment Center, Sun Yat-sen University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • The Affiliated Tumor Hospital
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • The First Affiliated Hospital - Soochow University
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Bethune Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi 'an Jiaotong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Shanhai Cancer Center
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • the Second Affiliated Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310003
      • The First Hospital affiliated to the Medical School of Zhejiang University
• France
  • Paris, France, 75010
    • Hôpital Saint Louis
  • Paris, France, 75651
    • Hospital de la Pitie-Salpetriere
  • Aquitaine
    • Pessac, Aquitaine, France, 33604
      • Hôpital Haut-Lévêque
  • Calvados
    • Caen, Calvados, France, 14000
      • Centre Hospitalier Universitaire de Caen - Hematologie Clinique IHBN
  • Lyon
    • Pierre-Bénite, Lyon, France, 69310
      • Hopital Lyon Sud
  • Nord
    • Lille, Nord, France, 59037
      • Hopital Claude Huriez - CHR Lille
  • Pays de la Loire Region
    • Nantes, Pays de la Loire Region, France, 44093
      • CHU Hotel Dieu Service Hematologie
  • Vienne
    • Poitiers, Vienne, France, 86000
      • CHU Poitiers - Pôle régional de Cancérologie
  • Île-de-France Region
    • Créteil, Île-de-France Region, France, 94010
      • Unite Hemopathies Lymphoides Hospital Henri Mondor
• Germany
  • Halle, Germany, 6120
    • University Hospital Halle Saale
  • Würzburg, Germany, 97080
    • Universitatsklinik Wurzburg, Med Klinik und Poliklinik II, Zentrum Innere Medizin
  • Gmund
    • Mutlangen, Gmund, Germany, D-73557
      • Kliniken Ostalb Stauferklinikum Schwab Gmund
• Italy
  • Bologna, Italy, 40138
    • University of Bologna Dipartimento di Medicina Specialistica Diagnostica e Sperimentale
  • Livorno, Italy, 57124
    • Uos Ematologia - Ospedale Civile di Livorno
  • Milan, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda - Division of Hematology
  • Novara, Italy, 28100
    • AOU Maggiore della Carita
  • Perugia, Italy, 6156
    • Presidio Ospedaliero Santa Maria della Misericordia
  • Ravenna, Italy, 48121
    • Ospedale Santa Maria Delle Croci
  • Reggio Emilia, Italy, 42123
    • Arcispedale Santa Maria Nuova
  • Varese, Italy, 21100
    • Ospedale dell'Angelo - Varese
  • Venice, Italy, 30174
    • Ospedale DellAngelo Di Mestre
  • Milan
    • Milan, Milan, Italy, 20122
      • UOC Hematologia, Fondazione IRCCS, Ca Granda, OM Policlinico
• Japan
  • Nagasaki, Japan, 852-8511
    • Japanese Red Cross Nagasaki Genbaku Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 466-8650
      • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
  • Aiti
    • Nagoya, Aiti, Japan, 460-0001
      • National Hospital Organization Nagoya Medical Center
  • Chiba
    • Chiba, Chiba, Japan, 260-8717
      • Chiba Cancer Center
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center
  • Hukuoka
    • Fukuoka, Hukuoka, Japan, 811-1395
      • National Hospital Organization National Kyushu Cancer Center
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
  • Kanagawa
    • Isehara-Shi, Kanagawa, Japan, 259-1193
      • Tokai University Hospital
  • Kyoto
    • Kyoto, Kyoto, Japan, 602-8566
      • University Hospital Kyoto Prefectural University of Medicine
  • Osaka
    • Osaka, Osaka, Japan, 545-8586
      • Osaka Metropolitan University Hospital
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center
  • Tokyo
    • Chuo Ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital - Tsukiji Campus
  • Yamagata
    • Yamagata, Yamagata, Japan, 990-9585
      • Yamagata University Hospital
• Poland
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie spSp. Z.o.o.
  • Lodz, Poland, 93-513
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)
  • Warsaw, Poland, 02-776
    • Instytut Hematologii I Transfuzjologii Klinika Hematologii
  • Wroclaw, Poland, 50-367
    • Uniwersytecki Szpital Kliniczny we Wroclawiu, Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Centrum Onkologii Instytut im M Sklodowskiej CurieOddzial Chorob United Kingdomladu Chlonnego
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-214
      • Uniwersyteckie Centrum
    • Gdynia, Pomeranian Voivodeship, Poland, 81519
      • Pomorskie Hospitals SP. Z O. O. Oncology And Radiotherapy Ward
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 217562
    • Icon Soc Farrer Park
• South Korea
  • Busan, South Korea, 49201
    • Dong-A University Hospital
  • Seoul, South Korea, 3080
    • Seoul National University Hospital
  • Seoul, South Korea, 6351
    • Samsung Medical Center
  • Seoul, South Korea, 3722
    • Severance Hospital
  • Seoul, South Korea, 6591
    • The Catholic University of Korea Seoul St Marys Hospital
  • Seoul, South Korea, 7985
    • Ewha Womans University Mokdong Hospital - Hemato Oncology
  • Daegu
    • Ulsan, Daegu, South Korea, 682-714
      • University of Ulsan College of Medicine
  • Gyeonggi-do
    • Gyeonggi-do, Gyeonggi-do, South Korea, 10408
      • National Cancer Center
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 8041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 8036
    • Hospital Clinic de Barcelona - Planta 4 Escalera
  • Madrid, Spain, 28040
    • Hospital Universitario Fundación Jiménez Díaz
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28050
    • Hospital Universitario Hm Sanchinarro
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
  • Valencia, Spain, 46026
    • Hospital Universitari i Politècnic La Fe
  • Balearic Islands
    • Palma, Balearic Islands, Spain, 07120
      • Hospital Universitari Son Espases
    • Palma, Balearic Islands, Spain, 07198
      • Hospital Son Llatzer
  • Catalonia
    • Barcelona, Catalonia, Spain, 8907
      • Ico Lhospitalet - Hospital Duran i Reynals
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Universitario Quiron Salud Madrid
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Chang Gung Memorial Hospital Kaohsiung
  • Taichung, Taiwan, 40447
    • China Medical University
  • Tainan, Taiwan, 704
    • National Cheng Kung University
  • Tainan, Taiwan, 736
    • Chi-Mei Medical Center - Liuying
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11490
    • Tri-Service General Hospital
  • Taipei, Taiwan, 11251
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation-
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • Royal Cornwall Hospital
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Derriford Hospital and the Royal Eye Infirmary
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • The Royal Marsden Hospital
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 4XW
      • University Hospital of Wales
• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack UMC
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medical College New York Presbyterian Hospital
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27257
      • Wake Forest Baptist Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center
  • Texas
    • Dallas, Texas, United States, 75390
      • Harold C. Simmons Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FL; Follicular lymphoma grade 1-3a cohort	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979
Experimental: DLBCL; Diffuse large B-cell lymphoma cohort	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979
Experimental: MCL; Mantle Cell Lymphoma cohort	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979
Experimental: MZL; Marginal Zone Lymphoma cohort	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979
Experimental: Other B-NHL; Other 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	Drug: Odronextamab; Administered by intravenous (IV) infusion; Other Names: REGN1979

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR, as assessed by independent central review	DLBCL/MCL/Other B-NHL	Up to 36 weeks of study treatment
Objective Response Rate (ORR), as assessed by independent central review	FL grade 1-3a/MZL	Up to 52 weeks of study treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Titer of anti-drug antibodies to odronextamab over time		12 weeks following end of treatment
ORR, as assessed by the local investigator	FL/MZL	Up to 52 weeks of study treatment
ORR, as assessed by the local investigator	DLBCL/MCL/Other B-NHL	Up to 36 weeks of study treatment
CR rate, as assessed by independent central review	FL grade 1-3a/MZL	Up to 52 weeks of study treatment
CR rate, as assessed by the local investigator	DLBCL/MCL/Other B-NHL	Up to 36 weeks of study treatment
CR rate, as assessed by independent central review	DLBCL/MCL/Other B-NHL	Up to 36 weeks of study treatment
PFS, as assessed by the local investigator		Approximately 194 weeks following the first dose
DOR, as assessed by the local investigator		Approximately 194 weeks following the first dose
DCR, as assessed by independent central review	DLBCL/MCL/Other B-NHL	Up to 36 weeks of study treatment
DCR, as assessed by the local investigator	DLBCL/MCL/Other B-NHL	Up to 36 weeks of study treatment
Concentration of odronextamab	End of infusion [EOI]; Concentration at a specified time t [Ct])	12 weeks following end of treatment
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).	Approximately 194 weeks following the first dose
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).	Approximately 194 weeks following the first dose
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.	Approximately 194 weeks following the first dose
Complete Response (CR) Rate, as assessed by the local investigator	FL grade 1-3a/MZL	Up to 52 weeks of study treatment
Progression-Free Survival (PFS), as assessed by independent central review		Approximately 194 weeks following the first dose
Overall Survival (OS)		Approximately 194 weeks following the first dose
Duration Of Response (DOR), as assessed by independent central review		Approximately 194 weeks following the first dose
Disease Control Rate (DCR), as assessed by independent central review	FL grade 1-3a/MZL	Up to 52 weeks of study treatment
DCR, as assessed by the local investigator	FL grade 1-3a/MZL	Up to 52 weeks of study treatment
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)		Approximately 194 weeks following the first dose
Incidence of Anti-Drug Antibodies (ADA) to odronextamab over time		12 weeks following end of treatment
Incidence of Neutralizing antibodies (Nab) to odronextamab over time		12 weeks following end of treatment

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): June 17, 2026
• Study Completion (Estimated): December 15, 2028

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: NHL; Follicular lymphoma (FL); CD20; bispecific antibody; Relapsed B-NHL; Refractory B-NHL; Diffuse large B-cell lymphoma (DLBCL); Mantle cell lymphoma (MCL); Marginal zone lymphoma (MZL)
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone
• Other Study ID Numbers: R1979-ONC-1625; 2017-002139-41 (EudraCT Number); 2024-511747-25-00 (Registry Identifier: CTIS number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing 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

• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No