AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

CD5CAR-NK cells for refractory invasive mold disease

This study is for people who have a severe fungal infection called 'invasive mold disease' that hasn't improved with standard treatments. Researchers are testing a new type of cell therapy, called CD5CAR-NK cells. This is a very early study (Phase I), which means it's the first time this treatment is being given to people. The main goal is to check if it's safe and to understand how it affects the body. It's a key first step to see if this new treatment could help patients who currently have limited options.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Enrolment target

Start

04 May 2026

refractory invasive mold disease

What is this study about?

This research study is about a serious illness called 'invasive mold disease.' This happens when a type of fungus gets into the body and causes a severe infection, often in people with weaker immune systems. For some patients, standard antifungal medicines don't work, and the infection keeps getting worse. We call this 'refractory' invasive mold disease.

Researchers are investigating a new and different approach using special cells called CD5CAR-NK cells. These are a type of immune cell, like the ones your body naturally uses to fight off infections. The idea is to make these cells even better at finding and fighting the fungal infection. This study will give these new cells to people for the first time.

Because this is the very first time humans are receiving this treatment, the main aims are to see if it's safe, what side effects it might cause, and how the body reacts to it. Finding out if it's safe is the most important step before we can learn if it actually helps to treat the infection.

Key takeaways

This is an early study for a serious fungal infection.
It tests a new cell therapy called CD5CAR-NK cells.
The main aim is to check if the new treatment is safe.
It's for adults with 'refractory' fungal disease (not responding to other treatments).
You can withdraw from the study at any time.

Who may be eligible?

This study is open to adults aged 18 and over. There is no upper age limit. Both men and women can take part.

To be considered for this study, you must have an invasive mold disease that has not gotten better with the usual treatments. This means your doctors have tried other medicines, but the infection is still active or getting worse.

There will be other detailed health checks to make sure this study is right for you and safe for you to participate. These checks will be explained by the study team.

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 an invasive mold disease?
Has your fungal infection not improved with other treatments?
Are you able to attend regular follow-up appointments?

Answer every question to see your result.

What does participation involve?

Taking part in this study will involve several visits to the clinic or hospital. You will have regular checks, which may include blood tests, scans, and other medical examinations to monitor your health and how your body is responding to the treatment. You will receive the new treatment, CD5CAR-NK cells, as part of the study.

After receiving the treatment, you will need to come back for follow-up visits over a certain period. These visits are important for the research team to continue monitoring your health, detect any side effects, and see how the treatment is working. The study team will explain the full schedule of appointments and tests. The total duration of your participation in the study, from your first visit to your final follow-up, will be clearly outlined by the study team.

Potential risks and benefits

Participating in an early-stage study like this means there are potential benefits and potential risks. The potential benefit is that this new treatment might help your severe fungal infection when other treatments haven't worked. However, because it's new, we don't know for sure if it will help, and it might not work for everyone. There are also potential risks, including side effects from the new treatment that are currently unknown. The study team will carefully monitor you for any side effects and will explain all known and possible risks. Remember, you can decide to stop participating in 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
Spain

Common questions

What is 'invasive mold disease'?

It's a serious infection caused by a type of fungus that gets into your body, often in people whose immune systems are not working well.

What does 'refractory' mean in this study?

It means the fungal infection hasn't gotten better or has kept getting worse, even after trying standard medicines.

What are CD5CAR-NK cells?

They are special immune cells that researchers are trying to use to fight the fungal infection more effectively.

Is this a new treatment?

Yes, this is an early-stage study, meaning it's the first time this specific treatment is being given to people.

What is the main goal of this study?

The main goal is to find out if the new treatment is safe for people and to understand how it works in the body.