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A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas

Sponsor: Regeneron Pharmaceuticals

NCT ID: NCT05685173

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Odronextamab (drug), REGN5837 (drug)
How long the study runs
Study runs about 81 months (dates as stated)
About the drug or intervention
Odronextamab — drug: Administered per the protocol · REGN5837 — drug: Administered per the protocol
Patient visit burden
Not specified by the sponsor

In plain English

This trial is testing whether a new drug called REGN5837, given together with a drug called odronextamab, is safe for adults with aggressive B-cell non-Hodgkin lymphoma (a cancer of white blood cells) that has come back or worsened after at least two previous treatments. The study is run by Regeneron Pharmaceuticals.

Who can take part

  • You have a type of lymphoma called CD20+ aggressive B-cell non-Hodgkin lymphoma that has got worse after at least two courses of treatment, including ones with an anti-CD20 antibody and an alkylating agent
  • Your disease can be measured on scans
  • You are well enough to carry out light activity (performance status 0 or 1)
  • Your bone marrow, kidneys and liver are working well enough
  • You can provide a sample of your tumour tissue
  • In the later part of the study, you may be asked to have tumour biopsies if a sample can be taken safely

Who may not be able to

  • You have had a stem cell transplant from a donor, or a solid organ transplant
  • You have had treatment with a bispecific antibody that targets CD20 and CD3, such as odronextamab
  • You have mantle cell lymphoma
  • You have lymphoma in the brain or spinal cord, or known spread there
  • You have had anti-lymphoma treatment recently (within 5 half-lives or 14 days, whichever is shorter)
  • You have had standard radiotherapy within 14 days of starting the study drug
  • You are taking more than 10 mg a day of steroid tablets (such as prednisone) within 72 hours of starting odronextamab
  • You have certain other health conditions or infections, as set out in the study protocol
  • You are allergic to both allopurinol and rasburicase

What taking part involves

  • • Taking the study drug REGN5837 together with odronextamab
  • • Providing tumour tissue samples, and possibly having tumour biopsies in the later part of the study

Time commitment: Number of visits, how long the trial lasts, and how the drugs are given are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
107
Started
2023-04-20
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for b-cell non-hodgkins lymphoma (b-nhl)
  • • Phase1 - 107 participants
  • • This study is researching an experimental drug called REGN5837 in combination with another drug, odronextamab (called "study drug\[s\]"), in patients with relapsed or refractory aggressive B-cell Non-Hodgkin Lymphomas (B-NHLs)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with b-cell non-hodgkins lymphoma (b-nhl)

Where?

  • • Truro - Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital
  • • Southampton - Southampton General Hospital
  • • Edinburgh - Western General Hospital
  • • Manchester - The Christie NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This study is researching an experimental drug called REGN5837 in combination with another drug, odronextamab (called "study drug\[s\]"), in patients with relapsed or refractory aggressive B-cell Non-Hodgkin Lymphomas (B-NHLs). The study has 2 parts. The aim of the first part (dose escalation) is to find a safe dose of REGN5837 when given in combination with odronextamab. The goal of the second part (dose expansion) is to use the REGN5837 drug dose found in the first part to see how well REGN5837 in combination with odronextamab works. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)

B-cell Non-Hodgkins Lymphoma (B-NHL)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD20CD3

Treatment history

Treatments you must have had:

  • ✓ for study enrollment

What the study is looking for

  • ✓cancer that can be measured on scans on cross sectional imaging as defined in the protocol
  • ✓activity scale (ECOG) performance status 0 or 1
  • ✓Adequate bone marrow, kidney and liver function as defined in the protocol
  • ✓Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor...

Who cannot take part

  • ✗Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20...
  • ✗Diagnosis of Mantle Cell Lymphoma (MCL)
  • ✗Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the...
  • ✗Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first...
  • ✗Standard radiotherapy within 14 days of first administration of the study treatment, as described in the protocol
See the full criteria
Key Inclusion Criteria: 1. Have documented CD20+ aggressive B-NHL, with disease that has progressed after at least 2 lines of systemic therapy containing an anti-CD20 antibody and an alkylating agent, as described in the protocol. 2. Measurable disease on cross sectional imaging as defined in the protocol 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 4. Adequate bone marrow, renal and hepatic function as defined in the protocol 5. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed 6. During dose expansion phase of the study, participant should be willing to undergo mandatory tumor biopsies, if in the opinion of the investigator, the participant has an accessible lesion that can be biopsied without significant risk to the participant. Key Exclusion Criteria: 1. Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab 2. Diagnosis of Mantle Cell Lymphoma (MCL) 3. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the protocol 4. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter, as described in the protocol 5. Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol 6. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab 7. Co-morbid conditions, as described in the protocol 8. Infections, as described in the protocol 9. Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicase NOTE: Other protocol defined inclusion / exclusion criteria apply

Where Is This Study? (4 UK sites)

Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital

Truro TR1 3LJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Abi Weeks

rch-tr.CornwallResearch@nhs.net01872 25 6424

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Donna Noonan

gwh.researchmanagement@nhs.net01793 605565

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

How to Get in Touch

Clinical Trials Administrator

Sponsor contact

CONTACT

844-734-6643 clinicaltrials@regeneron.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05