A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
This study is looking into an experimental drug called REGN5837, given alongside another drug called Odronextamab, for adults with aggressive B-cell Non-Hodgkin Lymphoma. This is for people whose lymphoma has returned or hasn't responded to earlier treatments. The study has two main parts. The first part aims to discover a safe dose of REGN5837 when used with Odronextamab. Once a safe dose is found, the second part will use that dose to see how effective the drug combination is. Researchers will also be checking for any side effects, how much of the drugs stay in the blood, and if the body makes antibodies that might affect the drugs' performance.
At a glance
What is this study about?
This research study is investigating an experimental treatment that involves two medications, REGN5837 and Odronextamab. These drugs are being tested in adults who have a type of cancer called aggressive B-cell Non-Hodgkin Lymphoma. This particular study is for people whose cancer has either come back after previous treatments or hasn't responded to those treatments.
The study has two main stages. The first stage is about finding the right amount of REGN5837 to give when it's combined with Odronextamab, making sure it's as safe as possible. Once that safe dose is decided, the second stage will give this specific dose to more people. The aim of this second stage is to see how well this combination of drugs actually works against the cancer.
Alongside checking for safety and effectiveness, the researchers will also be looking at other important things. They want to understand what side effects might occur, how the drugs move through the body by measuring them in the blood, and whether the body's immune system creates responses that could change how the drugs work.
Key takeaways
- This study is testing two new drugs for aggressive B-cell Non-Hodgkin Lymphoma.
- It's for people whose lymphoma has returned or hasn't responded to earlier treatments.
- The first stage aims to find a safe dose of the new combination.
- The second stage checks how effective this safe dose is.
- Side effects and how the body handles the drugs will be closely monitored.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you must be an adult with aggressive B-cell Non-Hodgkin Lymphoma that has either returned or not improved after at least two other types of treatment. This previous treatment must have included a specific group of medications for lymphoma.
You would need to have clear signs of the lymphoma that can be measured, often seen on scans. You should also generally be well enough to take part, meaning you can carry out most of your usual activities without too much difficulty. Your body's organs, like your blood, kidneys, and liver, need to be working well. The study also requires a sample of your tumour tissue, either from a past biopsy or sometimes a new one if it's safe to do.
There are also reasons why you might not be able to join. For example, if you've had certain types of transplants or particular lymphoma treatments recently. Conditions like Mantle Cell Lymphoma or lymphoma in your brain or spinal cord would also mean you can't participate. You'd also be excluded if you have certain other medical conditions, infections, or specific allergies, especially to some medications used to reduce side effects.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you an adult (18 or older)?
- Do you have aggressive B-cell Non-Hodgkin Lymphoma?
- Has your lymphoma returned or not responded to at least two previous treatments, including a specific type of drug?
- Are you generally well enough to do most daily activities?
- Are your kidneys, liver, and blood working generally well?
- Do you have a tumour sample available or can have one taken if safe?
What does participation involve?
If you decide to take part in this study, you would receive two study drugs: Odronextamab and REGN5837. The drugs are given together. In the first part of the study, the dose of REGN5837 would be gradually increased in different groups of participants to find the safest and most suitable amount. In the second part, everyone would receive the dose found to be safe. You would have regular check-ups, which might include blood tests, scans, and physical examinations, to monitor your health, how the drugs are affecting you, and how your lymphoma is responding. Your doctors will explain the exact schedule of visits and tests. The total duration of your participation would depend on how your body responds to the treatment and the study's design. Your medical team will explain the full details specific to your situation.
Potential risks and benefits
Locations (20)
- City of HopeVerified postcodeDuarte, United States· Recruiting
- University of California Los Angeles (UCLA) Medical CenterVerified postcodeSanta Monica, United States· Recruiting
- Norton Cancer InstituteVerified postcodeLouisville, United States· Recruiting
- Massachusetts General HospitalVerified postcodeBoston, United States· Recruiting
- Harvard Medical School - Beth Israel Deaconess Medical CenterVerified postcodeBoston, United States· Recruiting
- Rutgers Cancer Institute of New JerseyVerified postcodeNew Brunswick, United States· Recruiting
- NYU Langone Health Perlmutter Cancer CenterVerified postcodeNew York, United States· Recruiting
- Icahn School of Medicine at Mount SinaiVerified postcodeNew York, United States· Recruiting
- UT SouthwesternVerified postcodeDallas, United States· Recruiting
- CHU de BordeauxVerified postcodeTalence, France· Recruiting
- Hopital Saint LouisVerified postcodeParis, France· Recruiting
- Gustave RoussyVerified postcodeVillejuif, France· Recruiting
Common questions
What is aggressive B-cell Non-Hodgkin Lymphoma?
It's a fast-growing cancer that starts in white blood cells called B-cells. Aggressive means it grows quickly and needs treatment soon.
What does 'relapsed or refractory' mean?
Relapsed means your cancer came back after treatment. Refractory means your cancer didn't respond or stopped responding to previous treatments.
What is a 'Phase 1' study?
A Phase 1 study is the first stage of testing a new drug in humans. Its main goal is to find a safe dose and see what side effects might occur.
Will I get a placebo (dummy drug)?
No, in this study, all participants will receive the active study drugs, Odronextamab and REGN5837.
Who is funding this research?
The study is sponsored by Regeneron Pharmaceuticals, Inc., the company developing these drugs.
How to find out more
Clinical Trials Administrator
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.