AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

AdaptNK –Cell Therapy for High-risk Myeloid Disease

This research study, called AdaptNK, is exploring a new type of cell therapy for adults diagnosed with high-risk myeloid diseases. Specifically, it's for people with Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndromes (MDS) where previous treatments haven't worked or the disease has come back. This is an early-stage study (Phase I and II), which means researchers are primarily checking that the new treatment is safe for patients. They also want to see if it shows signs of being effective in fighting the disease. The study is open to both men and women aged 18 and over.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Karolinska Institutet

Enrolment target

Start

19 Jan 2026

Relapsed and/or refractory AML or MDS

What is this study about?

This study is looking into a new treatment called AdaptNK for certain blood conditions. These conditions are Acute Myeloid Leukaemia (AML) and Myelodysplastic Syndromes (MDS), which affect the blood and bone marrow. We're specifically interested in people who have a 'high-risk' form of these diseases, meaning their condition is difficult to treat, has come back after treatment, or hasn't responded to previous therapies.

The AdaptNK treatment uses a special type of cell therapy. In cell therapy, healthy cells are used to fight disease. Researchers want to find out if AdaptNK can be a safe and helpful new option for people facing these challenging conditions. Think of it like trying a new kind of key to unlock a problem that older keys couldn't open.

Because this is an early-stage study (called Phase I and Phase II), the main goals are to make sure the treatment is safe for patients and to see if it shows any signs of working. If the treatment proves safe and promising, it could potentially offer new hope for patients who currently have limited options.

Key takeaways

This study is for adults with high-risk AML or MDS where other treatments haven't worked.
It's testing a new cell therapy called AdaptNK.
The main goals are to check the treatment's safety and see if it helps.
It's an early-stage study, meaning it's a new and experimental treatment.
Participation involves clinic visits, assessments, and follow-up.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older – there's no upper age limit. The study is open to both men and women.

Crucially, you would need to have been diagnosed with either Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndromes (MDS) that are considered 'high-risk.' This means that your disease may have come back after treatment, or it hasn't responded to the usual treatments given for your condition.

Before taking part, a healthcare team would need to review your full medical history and current health to make sure this study is right for you. There will be other specific medical details they check to ensure your safety and that you fit the study's 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) or Myelodysplastic Syndromes (MDS)?
Has your AML or MDS either come back after treatment or not responded well to previous treatments?
Are you comfortable committing to regular clinic visits and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve several visits to the clinic for treatments and check-ups. You would receive the AdaptNK cell therapy as guided by the study doctors. You would also have regular assessments, which might include blood tests, scans, and other medical examinations to monitor your health and how the treatment is affecting your body and the disease. The total duration of your participation, including follow-up appointments, would be explained to you in detail by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new treatment that isn't widely available. It could also help doctors learn more about your condition and contribute to medical knowledge that benefits others in the future. However, as with any new treatment, there are potential risks and side effects that the AdaptNK therapy might cause. These will be fully explained to you before you decide to join. Remember, taking part is completely voluntary, and you are free 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
Sweden

Common questions

What is cell therapy?

Cell therapy uses special cells to help fight diseases, often by boosting your body's own ability to target unhealthy cells.

What are AML and MDS?

AML (Acute Myeloid Leukaemia) and MDS (Myelodysplastic Syndromes) are types of cancer that affect the blood and bone marrow.

What does 'relapsed and/or refractory' mean?

This means your disease has come back after treatment, or it hasn't responded well to previous treatments.

Is this a new treatment?

Yes, AdaptNK is a new, experimental treatment being tested in this study to see if it's safe and effective.

Will I get the new treatment for sure if I join?

If you meet all the study's requirements, you would receive the AdaptNK cell therapy. There isn't a placebo group in this type of study.