Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase 1/1b Open-Label Dose-Escalation and Dose-Optimization Study of Bcl-2 Inhibitor BGB 21447 in Patients With Mature B Cell Malignancies

This study is looking at a new potential medicine, BGB 21447, for adults who have specific types of blood cancer called mature B-cell malignancies. These are cancers that affect a certain kind of white blood cell. This is the very first time this new medicine is being given to people. The main goal is to find a safe dose and understand how the body handles the medicine. Researchers will also be checking to see if it shows any signs of working against the cancer. This step is crucial for developing new treatments for these conditions in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Beigene Ltd.

Enrolment target

Start

29 Sep 2025

mature B-Cell malignancies

What is this study about?

Imagine your body has tiny soldiers called white blood cells that fight off illness. In some types of cancer, these soldiers, specifically a type called B-cells, grow out of control. This study is for people who have certain cancers originating from these B-cells, which doctors call mature B-cell malignancies.

The researchers are testing a new medicine, BGB 21447, which is designed to target these specific cancer cells. This is the first time this medicine is being given to people, so it's a very early stage of research. The main aim is to carefully increase the dose in small steps to find the amount that is both safe and has the best chance of working effectively. They will closely watch how the medicine acts in the body and if it causes any side effects.

Finding safe and effective new medicines for cancer is a long process, and studies like this are very important first steps. The information gathered here will help doctors decide if this medicine is promising enough to test in larger groups of patients in the future, with the hope of providing new treatment options.

Key takeaways

This study is testing a new medicine for certain blood cancers.
It's a very early-stage study (Phase 1) focused on safety and dosage.
It's specifically for adults aged 18 and over.
Both men and women can participate.
Participation involves receiving the new medicine and regular health checks.

Who may be eligible?

To join this study, you must be an adult aged 18 years or older. Both men and women can take part.

Your doctor will need to confirm that you have a specific type of blood cancer called a mature B-cell malignancy. There will be other health checks and tests to make sure that taking part in the study would be safe for you and that you meet all the necessary requirements.

It's important to remember that not everyone with these conditions will be able to join, as there are strict guidelines to protect your safety during the trial.

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 mature B-cell malignancy?
Are you willing and able to attend regular clinic visits?
Are you able to understand and sign the consent form?
Are you a man or a woman?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the trial medicine, BGB 21447. As this is a dose-finding study, the amount of medicine you receive will be carefully decided by the study doctors. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and see how the medicine is affecting your body and your cancer. This includes looking for any side effects.

The study will involve several visits over a period, which your study team will explain in detail. There will also be follow-up appointments after you stop taking the medicine to ensure your health is still being monitored.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that you might be among the first to receive a new medicine that could help treat your specific type of cancer. However, it's also possible the medicine may not work for you, or it could cause side effects, some of which might be serious and not yet fully known. You will be closely monitored for any reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
France
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Unverified
Italy

Common questions

What kind of cancer is this study for?

This study is for people with specific types of blood cancer called 'mature B-cell malignancies'.

What does 'Phase 1' mean?

Phase 1 means this is one of the very first times this new medicine is being given to people. The main aim is to find a safe dose and see how the body handles it.

Will I definitely get the new medicine?

Yes, if you join this study, you will receive the new medicine, BGB 21447.

How long will I be in the study?

The exact length of time you'll be in the study will be explained by the research team, as it can vary depending on individual patient needs and the study design.

Can I leave the study if I change my mind?

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