Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Combined antitumor therapy with ex vivo manipulated dendritic cells producing interleukin-12 in children, adolescents and young adults with progressive, recurrent or primarily metastatic high-risk tumors

This study is looking into a new treatment for children, teenagers, and young adults who have high-risk cancers that have come back, spread, or are hard to treat. The treatment involves taking a patient's own immune cells, called dendritic cells, changing them in the lab to make them produce a substance called interleukin-12, and then giving them back to the patient. The idea is to make these special cells better at telling the body's immune system to attack cancer. This is a early-stage study (Phase I and II) which means the main focus is to carefully check how safe the treatment is and if there are any significant side effects. Researchers will also be looking to see if the treatment helps slow down the cancer's growth or shrink it.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Masarykova Univerzita

Enrolment target

Start

21 Nov 2024

Progressive recurrent or primarily metastatic high-risk paediatric malignancies

What is this study about?

This study is investigating a new and different way to treat certain cancers in children, teenagers, and young adults. Specifically, it's for those with 'high-risk' cancers that have either returned after treatment, spread to other parts of the body, or are very aggressive from the start. These types of cancers can be challenging to treat with standard methods, so doctors are always looking for new options.

The experimental treatment uses something called 'dendritic cells.' These are very important cells in your body's immune system, acting like messengers that tell other immune cells to fight off things like infections or, in this case, cancer. In this study, doctors take some of a patient’s own dendritic cells, gently modify them in a lab so they produce a signal molecule called interleukin-12, and then give them back to the patient. The hope is that these specially prepared cells will be better at guiding the immune system to find and destroy cancer cells.

This is an early-stage study, meaning it's one of the first times this specific treatment is being tested in people. The main goal for now is to understand how safe this treatment is and if patients experience any serious side effects. While safety is the priority, doctors will also be closely watching to see if the treatment has any positive effects on the cancer, like slowing its growth or making it shrink. This will help them decide if it's promising enough to be tested in larger studies in the future.

Key takeaways

It's a study for certain high-risk cancers in young people.
It tests a new treatment using your body's own immune cells.
The main focus is to check how safe the new treatment is.
Researchers will also look for signs that the treatment helps fight the cancer.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

This study is looking for patients aged 18 and older. While the trial title mentions children, adolescents, and young adults, the current available information states 18 years and above. If you are under 18, it is important to clarify this with your doctor.

Both males and females can take part in this study. The most important thing is that participants have a high-risk cancer that has come back, spread, or is difficult to treat initially.

Because this is a very specific type of treatment, your medical team will need to check many details about your health and your cancer to see if this study is potentially suitable for you. They will explain all the specific 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?
Do you have a cancer that has returned, spread, or is considered high-risk?
Have you discussed this trial with your specialist doctor?
Are you able to attend regular hospital visits for treatment and monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step would involve detailed medical checks to make sure the treatment is suitable for you. You would then undergo a procedure to collect some of your own immune cells, likely through a process similar to donating blood, but done in a hospital setting. These cells would then be sent to a special lab to be prepared for your treatment.

Once your special cells are ready, you would receive the treatment, which is typically given like a vaccine injection. The study would involve a series of hospital visits to monitor your health very closely, check for any side effects, and see how your body is responding to the treatment. This will include blood tests, scans, and physical examinations. The exact number and frequency of visits, as well as the total length of time you would be in the study, would be explained in detail by the study team. They will also tell you about any follow-up appointments after your treatment course is complete.

Potential risks and benefits

Participating in a clinical trial like this could offer potential benefits, such as access to a new treatment that isn't widely available yet, which might help when standard treatments haven't been fully effective. However, it's very important to remember that this is an experimental treatment, and its full effects are not yet known. There could be risks involved, including side effects from the treatment, some of which might be serious or unexpected. The study team will carefully monitor you for any problems. 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
Czechia

Common questions

What kind of cancer is this study for?

This study is for children, teenagers, and young adults who have certain high-risk cancers that have come back, spread, or are difficult to treat from the beginning.

What is 'interleukin-12'?

Interleukin-12 is a natural signal molecule in the body that helps the immune system fight off diseases, including cancer. In this study, special cells are designed to produce more of it.

Will this treatment cure my cancer?

This is an early-stage study, mainly focused on safety. While researchers hope it could help, it's not known if it will cure cancer. Doctors will be looking for any positive effects.

What does 'autologous' mean?

'Autologous' means that the cells used in the treatment come from your own body. They are taken out, changed in the lab, and then given back to you.

Can I stop being part of the study once I've started?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your regular medical care.