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

A Phase 1 Multicenter, Open Label, First-in-Human Dose Escalation Study of AFM28, a Bispecific ICE® that Targets CD123 and CD16A, in patients with CD123-Positive Relapsed/Refractory Acute Myeloid Leukemia

This is an early-stage medical study, often called a Phase 1 trial. It's looking into a new medicine named AFM28 for individuals diagnosed with a specific form of blood cancer known as acute myeloid leukaemia (AML). This particular study focuses on patients whose AML has either returned after treatment (relapsed) or hasn't responded well to previous therapies (refractory), and has a specific marker called CD123. The main goal is to find out if AFM28 is safe to use in people and to determine the best dose. Because this is the very first time this medicine is being given to humans, doctors will be carefully watching participants to understand how the medicine affects them. It's a key first step in understanding if AFM28 could become a future treatment option for AML.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Affimed GmbH, Affimed GmbH

Enrolment target

Start

08 Oct 2024

Refractory/relapsed (R/R) CD123-positive acute myeloid leukemia (AML)

What is this study about?

This study is a very early step in testing a new medicine for a type of blood cancer called acute myeloid leukaemia, or AML. If you or someone you know has AML that has come back after treatment or hasn't responded well to other medicines, this study might be relevant.

The new medicine is called AFM28. It's designed to specifically target certain cells related to AML. In this first study in humans, doctors want to find out two main things. Firstly, they want to check if AFM28 is safe to use. Because it's a new medicine, understanding its safety is the top priority. Secondly, they want to discover the right amount, or 'dose', of the medicine that works best while keeping side effects manageable.

This type of study often involves a small number of people and lasts for a significant period, during which the medical team closely monitors each participant. The information gathered from this study will be crucial for deciding if AFM28 should be tested in more people in later studies, moving it closer to potentially becoming a new treatment option for AML.

Key takeaways

This is an early-stage Phase 1 study testing a new medicine called AFM28.
It's for adults with acute myeloid leukaemia (AML) that has returned or not responded to previous treatments.
The new medicine targets a specific marker (CD123) on AML cells.
The main aims are to check the medicine's safety and find the best dose.
Study participants will be closely monitored by doctors and nurses.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. To be part of this research, you must have been diagnosed with acute myeloid leukaemia (AML).

Specifically, your AML must have either returned after previous treatments (what doctors call 'relapsed') or it hasn't responded adequately to other treatments (known as 'refractory' AML). Also, your AML cells need to have a specific marker on their surface called CD123 for you to be considered for this study.

There might be other health conditions or medications that could prevent you from joining, as the research team needs to make sure it's safe for you to take part. A doctor involved in the study would thoroughly check your medical history to see if you meet all the detailed requirements.

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 acute myeloid leukaemia (AML)?
Has your AML either come back after treatment, or not responded to previous treatments?
Has your doctor confirmed your AML cells have the CD123 marker?
Are you willing to have regular hospital visits and check-ups during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new medicine, AFM28. Since this is an early-stage study, the doctors and nurses will monitor you very closely. This will involve regular visits to the hospital, which may include physical examinations, blood tests, and other checks to see how the medicine is affecting your body and your AML.

The dosage of the medicine may be gradually increased for some participants as the study progresses, to find the most effective and safe amount. You will be asked to attend follow-up appointments for a period after your main treatment ends, to keep track of your health and the long-term effects of the medicine. The total duration of your involvement, including both treatment and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. The potential benefit of this study is that you might receive access to a new medicine that could help with your AML, especially if other treatments haven't worked well. However, because this is a first-in-human study, there's a risk that AFM28 might cause unexpected side effects that we don't yet know about. The study team will explain all known and potential risks to you. You are 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
France
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Unverified
Spain

Common questions

What is acute myeloid leukaemia (AML)?

AML is a type of cancer that starts in the bone marrow, the soft inner part of bones where new blood cells are made. It causes too many faulty white blood cells to be produced.

What does 'relapsed/refractory' mean?

Relapsed means the cancer has come back after treatment. Refractory means the cancer did not respond to previous treatments.

What is a Phase 1 study?

A Phase 1 study is the first time a new medicine is given to people. The main goals are to check its safety, understand how it works in the body, and find the right dose.

What is CD123?

CD123 is a specific marker that can be found on the surface of some AML cells. The new medicine, AFM28, is designed to target cells with this marker.

Will I get the new medicine?

Yes, all participants in this particular study will receive the new medicine, AFM28, as part of the research.