AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

PILOT ANTI-CMV CLINICAL TRIAL: PROPHYLAXIS OF CYTOMEGALOVIRUS INFECTION IN HLA-IDENTICAL FAMILIAL ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION WITH ADVANCED CELLULAR IMMUNOTHERAPY IN PATIENTS WITHOUT SPECIFIC PHARMACOLOGYCAL PROPHYLAXIS AVAILABLE

This research study is testing a new treatment to stop a common virus called Cytomegalovirus (CMV) from becoming active after a stem cell transplant. This type of transplant, where stem cells come from a closely matched family member, is used to treat certain serious blood conditions. CMV can cause problems after these transplants, and standard prevention methods aren't always available or effective for everyone. The study aims to find out if this new treatment can keep CMV from reactivating (meaning the virus becomes active again in the body) within the first 100 days after the transplant. We'll be looking carefully at how many people get CMV and need treatment, as well as checking their immune system's response to the virus. This is a very early-stage study, exploring whether this new approach is safe and potentially effective.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Instituto De Investigacion Marques De Valdecilla

Enrolment target

Start

17 Jan 2025

Cytomegalovirus infection post allogeneic allogeneic HLA-identical familial PHT

What is this study about?

When someone has a stem cell transplant – especially one using cells from a family member – their immune system is very weak. This makes them vulnerable to various infections. One common infection they can get is from a virus called Cytomegalovirus, or CMV. For many people, CMV is usually harmless, but after a transplant, it can cause serious problems.

Currently, there are medicines to help prevent CMV from flaring up, but these aren't always suitable or available for everyone. This study is testing a new way, using what's called advanced cellular immunotherapy, to try and prevent CMV infection in people who have had a stem cell transplant from a family member and don't have other specific CMV prevention medicines. It's a 'pilot' study, which means it's one of the first times this approach is being tested in humans.

The main goal of this study is to see how well this new treatment prevents CMV from becoming active in the body within the first 100 days after a stem cell transplant. We will be checking for the virus in blood samples. We'll also be looking at whether people need treatment for CMV and how their immune system learns to fight the virus. This type of research is crucial for finding better ways to protect patients after these important medical procedures.

Key takeaways

This study is testing a new way to prevent CMV infections after family donor stem cell transplants.
It's for adults (18+) who don't have other specific CMV prevention options.
The main goal is to see if the treatment stops CMV from flaring up in the first 100 days.
This is an early-stage (Phase I/II) study, meaning it's one of the first times it's used in humans.
Participation involves receiving the new therapy and regular blood tests to monitor for CMV.

Who may be eligible?

This study is looking for adults who are at least 18 years old and have no upper age limit. We are including both men and women in this research.

To be eligible, you must have recently had or be about to have a stem cell transplant where the cells come from a family member who is a very good match (this is called an 'HLA-identical familial allogeneic hematopoietic stem cell transplantation').

Crucially, you would also need to be someone for whom the usual preventative medicines for CMV are not available or suitable. The study team will check other specific medical criteria to make sure this study is right 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?
Have you recently had, or are you about to have, a stem cell transplant from a family member?
Are the usual CMV prevention medicines not suitable or available for you?
Are you prepared for regular hospital visits and blood tests after your transplant?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive the new experimental treatment. We will closely monitor you to see how your body responds and if the treatment helps prevent CMV infection. This will involve regular blood tests, especially in the first 100 days after your transplant. These blood tests will check for the presence of the CMV virus and also look at how your immune system is working. You will likely have several clinic visits for these checks and to discuss any side effects or concerns. The total duration of active follow-up for the primary outcome will be at least 100 days after your transplant, with further monitoring for secondary outcomes.

Potential risks and benefits

As this is an early-stage study, the potential benefits are not fully known, but the aim is to find a new way to prevent CMV infection, which could improve outcomes for future patients. Potential risks include side effects from the new treatment, which will be carefully monitored, and the possibility that the treatment may not work as intended. You have the right to withdraw from the study at any time without affecting your 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 CMV?

CMV (Cytomegalovirus) is a common virus. Most healthy people don't get sick from it, but it can cause serious problems for people with weakened immune systems, like after a stem cell transplant.

What is a stem cell transplant?

A stem cell transplant replaces unhealthy blood-forming cells with healthy ones. This study focuses on transplants where the healthy cells come from a closely matched family member.

What does 'first administration to humans' mean?

It means this new treatment is being given to people for the very first time in a research setting. This phase focuses on safety and finding the right dose.

How will you know if the treatment is working?

We'll regularly test your blood for CMV, looking for any signs of the virus. We'll also see if you need any extra treatment for CMV and how your body's immune system responds.

What if I already have CMV?

Most people have been exposed to CMV at some point. This study is about preventing the virus from becoming active and causing problems after a transplant, rather than treating an active infection immediately before the transplant.