Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Phase IB clinical trial to assess the safety, tolerability, and preliminary efficacy of AloCELYVIR (Mesenchymal allogenic cells + ICOVIR-5) in children, adolescent and young adults with newly diagnosed diffuse intrinsic pointine glioma (DIPG) in combination with radiotherapy or medulloblastoma in relapse/progression in monotherapy.

This research study is for children, teenagers, and young adults who have either a type of brain cancer recently diagnosed called Diffuse Intrinsic Pontine Glioma (DIPG), or another brain cancer called Medulloblastoma that has come back. The study is testing a new treatment called AloCelyvir. For DIPG, AloCelyvir would be given alongside standard radiotherapy. For medulloblastoma that has returned, it would be given on its own. The main goal is to find out if AloCelyvir is safe and well-tolerated, meaning it doesn't cause too many serious side effects. Researchers will also be looking for early signs of how effective the treatment might be at fighting the cancer and how patients' lives might be affected.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Enrolment target

Start

15 Mar 2023

Newly diagnosed Diffuse Intrinsic Pointine Glioma (DIPG) or Medulloblastoma in relapse/progression in children adolescents and young adults.

What is this study about?

This study is a research project focusing on a new treatment called AloCelyvir. It's designed for young patients who are facing serious brain cancers. Specifically, it's for children, teenagers, and young adults who have just been diagnosed with Diffuse Intrinsic Pontine Glioma (DIPG), or those whose Medulloblastoma has returned after previous treatment.

The main purpose of this early-stage study is to understand if AloCelyvir is safe. Doctors will carefully watch for any side effects and how well patients tolerate the treatment. They also want to see if there are any early signs that the treatment might be helping to control the cancer, such as how the tumours respond or how long patients live without the disease getting worse. This information is crucial for deciding if AloCelyvir should be studied further in larger trials.

The study involves giving AloCelyvir in different ways depending on the cancer type. For newly diagnosed DIPG, it will be given along with the usual radiation therapy. For medulloblastoma that has come back, AloCelyvir will be given by itself. By looking at things like how the body reacts to the treatment, including how the immune system responds and the levels of the treatment in the body, researchers hope to learn more about how AloCelyvir works.

Key takeaways

This study is testing a new treatment called AloCelyvir for children and young adults with two types of brain cancer.
It's an early-stage study, mainly focused on checking if the new treatment is safe and well-tolerated.
Patients either have newly diagnosed DIPG or medulloblastoma that has returned.
For DIPG, AloCelyvir is given with radiotherapy; for medulloblastoma, it's given alone.
Participation involves receiving the treatment and regular hospital visits for monitoring.
There are potential benefits (access to new treatment, helping science) and risks (unknown side effects).

Who may be eligible?

This study is looking for patients who are children, teenagers, and young adults, meaning from birth up to 18 years old. Both boys and girls can take part. You would need to have one of two specific types of brain cancer.

One group of patients who might be able to join are those who have just been diagnosed with Diffuse Intrinsic Pontine Glioma (DIPG). This means your diagnosis is recent, not that you've had it for a while.

The other group who might be eligible are those with Medulloblastoma that has returned or gotten worse after earlier treatment. This is sometimes called 'relapsed' or 'progressive' medulloblastoma. Your doctor will be able to tell you if your specific situation fits these descriptions.

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 under 18 years old?
Have you recently been diagnosed with DIPG?
Or has your medulloblastoma returned or gotten worse?
Are you able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new treatment, AloCelyvir. For newly diagnosed DIPG, you would receive AloCelyvir alongside your standard radiotherapy. If you have medulloblastoma that has returned, you would receive AloCelyvir on its own. This treatment involves carefully controlled doses.

You would need to attend regular visits to the hospital or clinic. During these visits, doctors and nurses would perform various assessments to check your health, look for any side effects, and see how the treatment is working. These might include physical examinations, blood tests, and scans. The study will continue for a period, during which you will be closely monitored. After the treatment period, there will be follow-up visits to track your progress and long-term health. The exact number and timing of visits and the total duration would be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn't widely available, which might help when standard treatments haven't worked or aren't sufficient. You would also contribute to medical knowledge, potentially helping others in the future. However, there are potential risks, as AloCelyvir is an experimental treatment and its full effects aren't yet known. There could be side effects, which might be mild or serious. The treatment may not work, or it could even make things worse for some patients. You have the right 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
Spain

Common questions

What is AloCelyvir?

AloCelyvir is a new treatment being tested in this study. It's made up of specific cells and something called ICOVIR-5, and researchers hope it can help fight certain brain cancers.

What is DIPG?

DIPG stands for Diffuse Intrinsic Pontine Glioma. It's a serious type of brain cancer that affects children and young adults, usually found in a part of the brainstem.

What does 'medulloblastoma in relapse/progression' mean?

This means that the medulloblastoma, another type of brain cancer, has either returned after being treated before, or is growing worse despite previous treatments.

What does 'Phase IB' mean?

This is an early stage of a clinical trial. It mainly focuses on finding out if the new treatment is safe and what dose can be given without causing too many serious side effects, rather than how well it cures the disease.

Will I get better if I join this study?

There's no guarantee that anyone will get better on this study. It's a research trial to learn more about a new treatment. We hope it may help, but it's important to understand it's not a proven cure.