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

A trial in patients with blood cancer and lymphatic system cancer looking at finding the optimal dose of BMF-219

This research study is for adults aged 18 and over who have different types of blood or lymphatic system cancers, such as certain leukaemias or lymphomas. These cancers include Acute lymphoblastic leukemia (ALL), Acute myeloid leukemia (AML), Acute mixed-phenotype leukemia (AMPL), Diffuse large B-cell lymphoma (DLBCL), Chronic lymphocytic leukemia (CLL), and Small lymphocytic lymphoma (SLL). The study is specifically for patients whose cancer has either returned after treatment (relapsed) or hasn't responded to previous treatments (refractory). This is a very early-stage trial, called a Phase I study. This means it's the first time this new medicine, BMF-219, is being given to people. The main goal is to find out what dose of BMF-219 is safe and works best for patients. Researchers will then use this information in future studies.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Biomea Fusion Inc.

Enrolment target

Start

08 Oct 2024

Relapsed or refractory (R/R) Acute lymphoblastic leukemia (ALL)R/R Acute myeloid leukemia (AML)R/R Acute mixed-phenotype leukemia (AMPL)R/R Diffuse large B-cell lymphoma (DLBCL)R/R Chronic lymphocytic leukemia (CLL)R/R Small lymphocytic lymphoma (SLL)

What is this study about?

This study is looking into a new medication called BMF-219. It's designed for people who have specific types of blood cancers or cancers of the lymphatic system. These cancers include different kinds of leukaemia (like Acute lymphoblastic, Acute myeloid, and Acute mixed-phenotype leukaemia) and lymphomas (such as Diffuse large B-cell lymphoma, Chronic lymphocytic leukaemia, and Small lymphocytic lymphoma). Participants in this study will be those whose cancer has returned after treatment or hasn't improved with other treatments they've tried.

This is a very early stage of research, known as a Phase I study. This is important because it's the very first time the new medicine, BMF-219, is being given to people. The main aim is to carefully test different amounts (doses) of BMF-219 to find out which dose is the safest and most effective for patients. The doctors will start with very low doses and gradually increase them, all while closely monitoring the patients for any effects.

The information gathered from this study, especially about the right dose of BMF-219, will be very valuable. It will help researchers decide how to continue testing this medicine in future, larger studies. The hope is to eventually find new and better ways to treat these types of cancer for patients whose current treatments are no longer working as well as hoped.

Key takeaways

The study is for adults with specific blood or lymphatic cancers.
It's for cancers that have returned or not responded to previous treatments.
It's an early-stage study (Phase I) to find a safe and effective dose of a new medicine (BMF-219).
Participation involves taking a new medicine and regular health checks.
Potential benefits include a new treatment option, but risks like side effects are possible.
You can withdraw from the study at any time.

Who may be eligible?

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

A key requirement is that you have been diagnosed with one of the specific blood or lymphatic cancers listed: Acute lymphoblastic leukemia (ALL), Acute myeloid leukemia (AML), Acute mixed-phenotype leukemia (AMPL), Diffuse large B-cell lymphoma (DLBCL), Chronic lymphocytic leukemia (CLL), or Small lymphocytic lymphoma (SLL).

Importantly, your cancer must have either come back after you've had treatment for it (doctors call this 'relapsed') or it hasn't responded to the treatments you've received so far (doctors call this 'refractory'). There will be other health checks and requirements you'll need to meet, which the study team will explain.

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 one of these types of cancer: Acute lymphoblastic leukemia (ALL), Acute myeloid leukemia (AML), Acute mixed-phenotype leukemia (AMPL), Diffuse large B-cell lymphoma (DLBCL), Chronic lymphocytic leukemia (CLL), or Small lymphocytic lymphoma (SLL)?
Has your cancer come back after treatment, or has it not responded to previous treatments?
Are you able to attend regular clinic appointments for checks and treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine, BMF-219. As this is a Phase I study, the main focus is on carefully finding the best dose. This means you might start on a very low dose, and it could be increased over time, always with close monitoring from the medical team.

You will have regular visits to the clinic, which will include examinations, blood tests, and possibly other scans or procedures to see how your body is reacting to the medicine and how your cancer is responding. The number and frequency of these visits will be explained by the study team, and they are usually more frequent at the beginning of the study.

The total length of time you'll be part of the study will vary, depending on how you respond to the treatment and the study plan. Even after you stop taking the study medicine, there will likely be follow-up appointments to ensure your health is stable. All your treatment and assessments that are part of the study will be provided at no cost to you.

Potential risks and benefits

Like all new medicines, BMF-219 may have potential benefits and potential risks. A possible benefit is that the new medicine might help control your cancer, especially if other treatments haven't worked well for you. However, as this is an early-stage study, we don't yet know how effective it will be. Possible risks include side effects from the medication. The study team will monitor you very closely for any side effects and will explain all known and potential risks to you in detail. You are always free 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
Spain
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Unverified
Netherlands

Common questions

What does 'relapsed or refractory' mean?

'Relapsed' means your cancer has come back after treatment. 'Refractory' means your cancer hasn't responded to treatments you've already had.

What is a Phase I study?

A Phase I study is the first time a new medicine is tested in people. The main goal is to find a safe dose and see how the body handles the medicine.

Will I know if I'm getting the active medication?

Yes, in this type of study, everyone receives the new medicine, BMF-219. The focus is on finding the right dose.

Will I have to pay to be in the study?

No, all study-related treatments, tests, and care will be provided at no cost to you.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your future medical care.