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Non-Hodgkin LymphomaPhase 1ELM-1NCT02290951

Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

A Phase 1 study testing Odronextamab multiple dose levels in people with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by Regeneron Pharmaceuticals at 22 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Odronextamab multiple dose levels
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
22 sitesin 5 countries
Study dates
9 Jan 2015to 21 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Have documented CD20+ B-cell malignancy, with active disease not responsive to prior therapy, for whom no standard of care options exists, and for whom treatment with an anti-CD20 antibody may be appropriate:
  • Part A (IV administration) B-NHL confirmed by National Cancer Institute (NCI) working group criteria
  • Part B (SC administration): Confirmed diagnosis of B-NHL requiring therapy as defined by WHO classification 2017
  • Patients with B-NHL must have had prior treatment with an anti-CD20 antibody therapy. Patients with CLL (Part A only) are not required to have received prior treatment with an anti-CD20 antibody therapy as defined in the protocol.
  • For the inclusion in the disease-specific expansion cohort enrolling DLBCL patients after failure of CAR-T therapy, the patient must have recovered from the toxicities of the lymphodepletion therapy and CAR-T infusion.
  • For inclusion in Part B, patients must have FL grade 1-3a or DLBCL (with or without prior CAR-T) per the criteria above, and:
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  • Patients with FL grade 1-3a and DLBCL must have received at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent
  • All patients must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT or MRI scan, if CT scan is not feasible.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Life expectancy of at least 6 months
  • Adequate bone marrow function as described in the protocol
  • Adequate organ function as described in the protocol
  • Willingness to undergo mandatory tumor biopsy pretreatment, if in the opinion of the investigator, the patient has an accessible lesion that can be biopsied without significant risk to the patient.
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent or legally acceptable representative

Who cannot join

  • Primary central nervous system (CNS) lymphoma or known or suspected CNS involvement by non-primary CNS NHL
  • History of or current relevant CNS pathology such as
  • Epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis, or
  • Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI
  • Standard anti-lymphoma chemotherapy (non-biologic) or radiotherapy within 28 days prior to first administration of study drug
  • Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) infection [(as noted by detectable levels on a blood polymerase chain reaction (PCR) assay)].
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  • Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus deoxyribonucleic acid (DNA) that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted upon consultation with the physician managing the infection.
  • Patients who show detectable levels of CMV at screening will need to be treated with appropriate antiviral therapy and demonstrate at least 2 undetectable levels of CMV by PCR assay (at least 7 days apart) before being re-considered for eligibility.
  • Patients who have received a live vaccination within 28 days of first dose of study treatment
  • Note: Other protocol Inclusion/Exclusion criteria apply

Trial locations and contacts

22 sites in 5 countries.

22 sites in 5 countries

United States10 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute (Massachusetts General Hospital and Beth Israel)

    Boston, Massachusetts, 02215

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Weill Cornell Medical College

    New York, New York, 10065

  • University of California, Irvine

    Orange, California, 92868

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Stanford University

    Stanford, California, 94305

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Israel6 sites

  • Assuta Ashdod University Hospital

    Ashdod, Southern District, 7747629

  • Rambam Health Care Campus - Hematology and Bone Marrow Transplantation Institute

    Haifa, 3109601

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, Central District, 44281

  • The Chaim Sheba Medical Center

    Tel-Hashomer, Central District, 5265601

Other trials in Israel

France3 sites

  • CHU Hôpital Lyon Sud

    Lyon, 69495

  • Centre Henri Becquerel

    Rouen, Haute-Normandie, 76038

  • Institut Gustave Roussy

    Villejuif, Île-de-France Region, 94800

Other trials in France

United Kingdom2 sites

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Royal Cornwall Hospitals NHS Trust

    Truro, Cornwall, tr1 3lq

Other trials in United Kingdom

Germany1 site

  • Universitatsklinikum Wurzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

About this study

Official title: An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With CD20+ B-Cell Malignancies Previously Treated With CD20-Directed Antibody Therapy (ELM-1)

This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL.

Being tested
Odronextamab multiple dose levels
Keywords
Diffuse large B-cell lymphoma (DLBCL), Follicular lymphoma (FL), Aggressive lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular

What participants receive

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

  • Odronextamab multiple dose levelsDrug

    Also called REGN1979

    Administered by intravenous (IV) infusion

  • Odronextamab multiple dose levelsDrug

    Also called REGN1979

    Administered by subcutaneous (SC) injection

Study groups in NCT02290951
Study groupRoleWhat they receive
Part AExperimentalDLBCL post CAR-T
Receives: Drug: Odronextamab multiple dose levels
1N Part BExperimentalFL
Receives: Drug: Odronextamab multiple dose levels
2N Part BExperimentalDLBCL
Receives: Drug: Odronextamab multiple dose levels

What is being measured

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

  1. Safety/overall frequency of adverse events (AEs)

    Part A and B

    Measured: Up to 24 months

  2. Safety/dose limiting toxicities (DLTs)

    Part A and B

    Measured: Up to 28 days

  3. Antitumor activity as measured by the objective response rate (ORR)

    Expansion Cohorts:

    • Diffuse large B-cell lymphoma (DLBCL) after failure of CAR-T therapy

    Part A

    Measured: Through study completion, an average of 24 months

Secondary outcomes (10)

  1. Pharmacokinetics (Concentration of odronextamab)

    Peak plasma concentration (Cmax) of odronextamab

    Part A and B

    Measured: Up to 10 months

  2. Incidence of anti-drug antibodies (ADA) to odronextamab

    Part A and B

    Measured: Over time; up to approximately 15 months

  3. Titer of ADA to odronextamab

    Part A and B

    Measured: Over time; up to approximately 15 months

  4. Incidence of neutralizing antibodies (NAb) to odronextamab over time

    Part A and B

    Measured: Over time; Up to approximately 15 months

  5. Objective response rate (ORR)

    For dose escalation portion and expansion cohorts:

    • Aggressive lymphoma expansion cohort 2
    • FL grade 1-3a expansion cohorts 1 and 2 (Part A)

    For dose escalation and dose expansion cohorts:

    • FL grade 1-3a
    • DLBCL
    • DLBCL post CAR T failure (Part B)

    Measured: Through study completion, an average of 24 months

  6. Progression-free survival

    Part A and B

    Measured: Up to 48 months

  7. Overall Survival

    Part A and B

    Measured: Until death or lost to follow-up/ withdrawal, approximately up to 48 months

  8. Duration of response (DOR)

    Part A and B

    Measured: Until progression, approximately up to 48 months

  9. Minimal residual disease (MRD) for patients with CLL

    Part A

    Measured: Up to 24 months

  10. Duration of Complete Response (DOCR)

    Part B

    Measured: Until progression, approximately up to 48 months

Timeline

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

  1. First posted14 Nov 2014 (estimated)
  2. Study start9 Jan 2015
  3. Primary completion21 Aug 2025
  4. Study completion21 Aug 2025

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02290951
Sponsor's protocol ID
R1979-HM-1333
Other IDs
2015-004491-30, 2024-514938-20-00, 2015
Acronym
ELM-1
Status last verified
Aug 2025
First submitted
7 Nov 2014
Last updated
10 Oct 2025
Results posted
No
Data monitoring committee
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

  • Bayly-McCredie E, Prince HM, Yannakou CK, Fiorenza S. An evaluation of odronextamab for the treatment of multiple subtypes of relapsed/refractory B-cell non-Hodgkin lymphoma. Expert Opin Biol Ther. 2025 Apr;25(4):331-343. doi: 10.1080/14712598.2025.2479631. Epub 2025 Mar 24.

    PubMed 40106587

  • Topp MS, Matasar M, Allan JN, Ansell SM, Barnes JA, Arnason JE, Michot JM, Goldschmidt N, O'Brien SM, Abadi U, Avivi I, Cheng Y, Flink DM, Zhu M, Brouwer-Visser J, Chaudhry A, Mohamed H, Ambati S, Crombie JL. Odronextamab monotherapy in R/R DLBCL after progression with CAR T-cell therapy: primary analysis of the ELM-1 study. Blood. 2025 Apr 3;145(14):1498-1509. doi: 10.1182/blood.2024027044.

    PubMed 39786390

  • Bannerji R, Arnason JE, Advani RH, Brown JR, Allan JN, Ansell SM, Barnes JA, O'Brien SM, Chavez JC, Duell J, Rosenwald A, Crombie JL, Ufkin M, Li J, Zhu M, Ambati SR, Chaudhry A, Lowy I, Topp MS. Odronextamab, a human CD20xCD3 bispecific antibody in patients with CD20-positive B-cell malignancies (ELM-1): results from the relapsed or refractory non-Hodgkin lymphoma cohort in a single-arm, multicentre, phase 1 trial. Lancet Haematol. 2022 May;9(5):e327-e339. doi: 10.1016/S2352-3026(22)00072-2. Epub 2022 Apr 1.

    PubMed 35366963

  • Zhu M, Olson K, Kirshner JR, Khaksar Toroghi M, Yan H, Haber L, Meagher C, Flink DM, Ambati SR, Davis JD, DiCioccio AT, Smith EJ, Retter MW. Translational findings for odronextamab: From preclinical research to a first-in-human study in patients with CD20+ B-cell malignancies. Clin Transl Sci. 2022 Apr;15(4):954-966. doi: 10.1111/cts.13212. Epub 2022 Jan 7.

    PubMed 34997701

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Odronextamab multiple dose levels in people with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by Regeneron Pharmaceuticals at 22 sites in 5 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 15 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: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Israel, France, United Kingdom, Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety/overall frequency of adverse events (AEs) (time frame: Up to 24 months). The study lists 3 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 NCT02290951, 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 10 Oct 2025.

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