Active not recruitingPHASE1INTERVENTIONAL

First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228

This study is looking at a new medicine called BYON4228, given with Rituximab, for people with lymphoma. Lymphoma is a cancer that affects white blood cells. This new medicine aims to work by targeting specific cells involved in the immune system to help fight the cancer. This is the very first time BYON4228 is being tested in humans. The study will happen in two parts: first, finding the safest and most effective dose, and then testing that dose in more people to see how well it works and if there are any side effects. It's for people whose lymphoma hasn't responded to at least two previous treatments. Anyone aged 18 or over, male or female, may be able to take part.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Byondis B.V.

Enrolment target

Start

04 Mar 2024

Estimated completion

01 May 2026

Lymphoma

What is this study about?

This study is testing a new medicine called BYON4228, given with another medicine called Rituximab. The main goal is to find out if BYON4228 is safe and how well it works in people with certain types of lymphoma. Lymphoma is a cancer that starts in white blood cells, which are part of your immune system. Unfortunately, sometimes lymphoma doesn't respond well to standard treatments, and new options are needed.

BYON4228 is a specially designed medicine that targets a specific protein on some immune cells. By blocking this protein, it's hoped that BYON4228 can help your body's immune system recognise and fight the cancer cells more effectively. Rituximab is a well-known medicine that is already used to treat some lymphomas, so the researchers want to see if combining these two medicines is a good strategy.

This is the very first time BYON4228 is being given to people. The study will happen in two steps: first, a small number of people will receive increasing doses of BYON4228 to find the safest dose and how often it should be given. Then, more people will receive that chosen dose to gather more information on how well it works and any side effects. This research is important because it could lead to new ways to treat lymphoma for people who haven't had success with other treatments.

Key takeaways

This study is for adults with lymphoma that hasn't responded well to previous treatments.
It tests a new medicine (BYON4228) combined with an existing one (Rituximab).
It's the first time BYON4228 is being tested in people.
The study aims to find a safe dose and see how well the treatment works.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

This study is particularly looking for adults (aged 18 or over) who have a type of blood cancer called lymphoma. Specifically, your lymphoma needs to be a type that produces a marker called CD20, and it must have come back or not responded well after at least two previous treatments.

In the second part of the study, they are looking for people with specific types of lymphoma: diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), marginal zone lymphoma, or follicular lymphoma (Grades 1-3a). Again, your lymphoma would need to have come back or not responded well to treatments.

Before taking part, doctors will perform checks to make sure your body is healthy enough for the study, including blood tests and a look at your general fitness. There are also some health conditions that would prevent you from taking part, such as certain past treatments, specific autoimmune diseases, or severe heart problems within the last six months. They also can't include people with a type of lymphoma called Burkitt's lymphoma.

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 18 years old or older?
Have you been diagnosed with a type of lymphoma that has CD20?
Has your lymphoma come back or not responded well to at least two previous treatments?
Are you generally feeling well and able to manage daily activities?
Do you have certain serious health conditions like severe heart disease or active autoimmune disorders?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine BYON4228 along with Rituximab. The BYON4228 is given by a drip into your vein. Initially, the study will involve finding the right dose, which means different participants might receive different amounts of the medicine. Throughout the study, you would have regular visits to the hospital for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. The doctors and nurses will explain how often these visits will be. You would also have an initial assessment to ensure you are suitable for the study. The total duration of your participation would depend on how your body responds to the treatment.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to a new experimental medicine that could help if your lymphoma hasn't responded to other treatments. However, as this is a new medicine, there are potential risks, including unknown side effects that could range from mild to serious. The medical team will carefully monitor you for any problems. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

ASST Spedali Civili di Brescia
Verified postcode
Brescia, Italy
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
Verified postcode
Candiolo, Italy
Instituto Europeo di Oncologia
Verified postcode
Milan, Italy
IRCCS Ospedale San Raffaele
Verified postcode
Milan, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS IRST
Verified postcode
Ravenna, Italy
Vrije Universiteit Medisch Centrum
Verified postcode
Amsterdam, Netherlands
Radboud UMC
Verified postcode
Nijmegen, Netherlands
Hospital Universitari Vall d'Hebron
Verified postcode
Barcelona, Spain
Institut Català d'Oncologia
Verified postcode
Barcelona, Spain
Centro Integral Oncológico Clara Campal (CIOCC) Hospital Universitario HM Sanchinarro
Verified postcode
Madrid, Spain
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom
University Hospitals Plymouth NHS Trust
Verified postcode
Plymouth, United Kingdom

Common questions

What is lymphoma?

Lymphoma is a cancer that starts in white blood cells (lymphocytes), which are part of your body's immune system.

What does 'first-in-human' mean?

It means this is the very first time this new medicine, BYON4228, is being given to people after being tested in laboratories and animals.

What is Rituximab?

Rituximab is a medicine already used to treat certain types of lymphoma, working by targeting a specific protein on cancer cells.

Why is there a dose escalation part?

The goal is to find the safest and most effective dose of BYON4228 before testing it in a larger group of people.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any time for any reason, without it affecting your future medical care.