AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

Phase Ia/Ib Study of UBX-303061 in Subjects with Relapsed/Refractory B-Cell Malignancies

This study is an important first step to learn about a new medicine called UBX-303061. It's designed for adults in the UK who have a type of blood cancer called B-cell malignancy, specifically if their cancer has come back or hasn't responded to previous treatments. Because this is the very first time humans will receive this medicine, the main goal is to carefully check if it's safe and to see how the body reacts to it. Doctors will also start to look for any signs that it might be working against the cancer. This kind of early study helps researchers decide if a new medicine is promising enough to be studied in larger groups of people later on.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Ubix Therapeutics Inc.

Enrolment target

Start

11 Jan 2025

B-cell malignancies

What is this study about?

This study is about a new medicine, UBX-303061, for people with certain types of blood cancers, known as B-cell malignancies. These are cancers that affect a specific type of white blood cell called B-cells. This study is for those whose cancer has either returned after treatment or hasn't responded well to previous treatments.

This particular study is a very early stage of research, often called a 'Phase 1' study. This means it's the first time this new medicine is being given to people. The main purpose at this stage is to make sure the medicine is safe and to see how the body handles it. Doctors will give very small doses at first and slowly increase them to find the safest and most effective amount. They will also be looking closely for any side effects.

Finding new ways to treat cancer is a long and careful process. Studies like this one are absolutely essential as they lay the groundwork for understanding new potential treatments. It helps researchers decide if a new medicine has the potential to help patients and should be investigated further in larger studies.

Key takeaways

Researches a new medicine (UBX-303061) for B-cell blood cancers.
For adults whose cancer has returned or didn't respond to previous treatments.
This is the first time this medicine is given to people (Phase 1 study).
Main goal is to check safety and how the body handles the medicine.
Involves close monitoring with regular doctor visits and tests.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is specifically for adults, meaning you need to be 18 years old or older to take part. There is no upper age limit, so older adults can also be considered.

It is open to both men and women. The specific type of cancer you have is important: you must have a B-cell malignancy that has either returned after you've had treatment, or it hasn't responded well to treatments you've tried before. This means your doctors have already tried other ways to treat your cancer, and these haven't been as successful as hoped.

To ensure your safety, the study team will carefully check your overall health and medical history. They will need to make sure that taking part in the study would be safe for you, and that the medicine won't interfere with other medical conditions you might have or treatments you're currently receiving.

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?
Do you have a B-cell blood cancer?
Has your cancer come back or not responded to past treatments?
Are you able to attend regular clinic visits?
Are you generally well enough to try a new treatment, as judged by your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, UBX-303061. This is a very early study, so it involves frequent visits to the clinic, especially at the beginning, so that doctors can closely monitor your health and how you react to the medicine. These visits will include check-ups, blood tests, and other assessments to monitor your body's response and watch for any side effects. The study team will explain exactly how often you'd need to visit and what each visit would involve. This careful monitoring is important because it's the first time this medicine is being given to people. The total duration of your participation would be explained by the study team, and it would likely involve an initial treatment period followed by a period of observation.

Potential risks and benefits

Taking part in this study means you could be among the first people to receive a new medicine that might lead to a future treatment for B-cell malignancies. While there's no guarantee it will help your cancer, you would receive close medical attention and monitoring. However, because this is a new medicine, there might be side effects that are not yet fully known. The study team will discuss all potential risks and side effects with you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Poland

Common questions

What is a 'B-cell malignancy'?

It's a type of cancer that starts in certain white blood cells called B-cells, which are part of your immune system. Examples include some types of lymphoma and leukaemia.

What does 'relapsed/refractory' mean?

It means your cancer has either come back after treatment (relapsed) or hasn't responded well to the treatments you've already had (refractory).

What is a 'Phase 1' study?

It's the very first stage of human testing for a new medicine. The main goals are to check its safety, find the right dose, and see how the body reacts to it.

Will I get the actual new medicine, or a dummy treatment?

In a Phase 1 study like this, all participants typically receive the active new medicine. There usually isn't a dummy treatment (placebo) used at this very early stage.

How long would I need to be involved in the study?

The exact duration will depend on a few things and will be explained by the study team, but these early studies often involve an initial treatment and close monitoring period, followed by observation.