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

Phase 1 trial of LAVA-1266, a CD123-targeting bispecific Vγ9Vδ2-T cell engager, in patients with CD123 positive relapsed/refractory (R/R) acute myeloid leukemia (AML) and intermediate risk, high risk, or extremely high-risk myelodysplastic syndrome (MDS)

This is an early-stage study, called a Phase 1 trial, looking into a new treatment named LAVA-1266. It's designed for adults aged 18 and over who have specific forms of acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS). These are blood cancers where the previous treatments haven't worked well, or the cancer has returned. The main goal of this first-in-human study is to check how safe the new drug is and to find the best dose. Researchers also want to see if it has any positive effects on the cancer. While this is a very early step, studies like this are crucial for developing new medicines to help people with these serious conditions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

LAVA Therapeutics N.V.

Enrolment target

Start

19 Mar 2025

CD123 positive R/R AML and intermediate risk high risk or extremely high risk MDS.

What is this study about?

This study is about a new medicine called LAVA-1266. It's designed to treat two types of blood cancer: acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS). Both of these conditions affect the blood and bone marrow, which is where new blood cells are made. The study is for people whose cancer has come back after treatment or hasn't responded to their current treatments.

The drug LAVA-1266 is a special type of medicine. It works by targeting a specific protein called CD123, which is found on some cancer cells. The drug helps your body's immune system, specifically certain white blood cells called Vγ9Vδ2-T cells, to recognise and fight these cancer cells more effectively. This is a very early study, meaning it's the first time this drug is being given to people.

We don't yet know if this new medicine will work or how it will affect people, but studies like this are a vital step in discovering new ways to treat serious illnesses. By taking part, you could help researchers learn more about LAVA-1266, which could potentially benefit future patients.

Key takeaways

This is an early-stage study (Phase 1) of a new drug called LAVA-1266.
It's for adults with specific types of AML or MDS that haven't responded well to previous treatments.
The drug aims to help your immune system fight cancer cells with a marker called CD123.
The main goals are to check the drug's safety and find the best dose.
Participation involves regular clinic visits for monitoring and assessments.
Joining is voluntary, and you can leave the study at any time.

Who may be eligible?

To join this study, you must be 18 years old or older. The study is open to both men and women.

You would be considered for this study if you have acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) that tests positive for a specific marker called CD123. This means the cancer cells have this particular feature. Importantly, your AML or MDS must be what doctors call 'relapsed/refractory' – this means it has either come back after you've had treatment, or it hasn't responded well to the treatments you've received so far.

For those with MDS, your condition would also need to be classified by doctors as 'intermediate risk', 'high risk', or 'extremely high risk'. The medical team will check all your details to see if this study is the right fit for you.

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 acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)?
Has your condition come back or not responded well to previous treatments?
Do your cancer cells have the CD123 marker?
If you have MDS, has your doctor told you it is intermediate, high, or extremely high risk?

Answer every question to see your result.

What does participation involve?

As this is a very early study, taking part will involve regular visits to the clinic so the medical team can closely monitor your health. You will receive the new drug, LAVA-1266, under careful supervision. At each visit, you'll likely have blood tests, physical examinations, and other assessments to check how your body is reacting to the treatment and to look for any side effects. The exact schedule of visits, tests, and the duration of the treatment will be explained in detail by the study team. You'll also have a follow-up period after your last dose to ensure everything is well.

Potential risks and benefits

Participating in this study might offer a chance to try a new treatment for your condition that isn't widely available yet. While there's no guarantee, the treatment might help your AML or MDS. However, like all medicines, LAVA-1266 could have side effects, which might be mild or more serious, and some unexpected risks might be discovered. The study team will closely monitor you for any problems. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future 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
Spain

Common questions

What does 'Phase 1' mean for this study?

Phase 1 means this is the first time the new drug, LAVA-1266, is being tested in humans. The main goals are to check its safety and find the right dose.

What are AML and MDS?

AML (acute myeloid leukaemia) and MDS (myelodysplastic syndrome) are serious conditions that affect your blood and bone marrow, where blood cells are made.

What does 'relapsed/refractory' mean?

It means your condition has either come back after previous treatment, or it hasn't responded well to the treatments you've had so far.

What is CD123?

CD123 is a specific marker that can be found on some cancer cells. This new drug is designed to target cells that have this marker.

Will this drug cure my condition?

It's too early to say if this drug will cure the condition. This early study aims to see if it's safe and if it might have any positive effects.