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)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (4 UK sites)
Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital
Truro TR1 3LJ, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
Clinical Trials Administrator
Sponsor contactCONTACT
