Active not recruitingNAINTERVENTIONAL

CMV-specific Donor-derived T Lymphocytes for the Treatment of Recalcitrant CMV Infection in a Patient With Primary Immunodeficiency

This study is about exploring a new treatment for very serious cytomegalovirus (CMV) infection in children and young people whose immune system isn't working well. CMV can cause widespread problems, including lung infections. If standard treatments haven't helped, this study offers a different approach. It involves giving patients special virus-fighting cells, called T lymphocytes, which come from a donor. These cells are specifically trained to target and destroy the CMV virus. The goal is to see if these donor cells can help the patient get rid of the infection and recover. This is important for patients with a condition where their body struggles to fight off infections on its own.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Calgary

Enrolment target

Start

15 Apr 2025

Estimated completion

01 Apr 2040

Cytomegalovirus Viremia Cytomegalovirus Pneumonia T-Lymphocyte Immunodeficiency

What is this study about?

Imagine your body's immune system as a team of soldiers designed to fight off invaders like viruses. For some children and young people, this immune system team is very weak, making it hard to fight off common infections that others might manage easily. One such infection is called Cytomegalovirus, or CMV. For someone with a weak immune system, CMV can become very serious, causing problems like lung infections (pneumonia) and spreading widely throughout the body.

This study is looking at a new treatment for these severe CMV infections when other medicines haven't worked. The treatment uses special cells called T lymphocytes, which are like the 'snipers' of your immune system, specifically trained to find and destroy viruses. In this case, these T lymphocytes come from a donor and are specifically chosen because they are good at fighting CMV. The idea is to give these donor cells to the patient, helping their own weakened immune system combat the virus more effectively.

This research is important because it could offer hope to young patients with very weak immune systems who are struggling with a difficult CMV infection. By introducing these special virus-fighting cells, doctors hope to help the body clear the infection and improve the patient's health.

Key takeaways

This study explores a new cell-based treatment for serious CMV infection.
It's for young female patients (0-20 years) with a very weak immune system.
The treatment uses special donor cells to target the CMV virus.
It's an option when other CMV treatments haven't worked well.
If you join, you'll have regular follow-up appointments for many years.

Who may be eligible?

This study is for female patients between 0 and 20 years old who have a very serious immune system problem that makes it hard for them to fight off infections. They must currently have an active cytomegalovirus (CMV) infection that has spread throughout their body and caused a lung infection (pneumonia).

However, some things might prevent someone from joining. You wouldn't be able to join if you are currently taking a high dose of steroid medication, or if you are on other specific medications that suppress your immune system or affect certain immune cells. This also includes some newer cancer medications or if you've recently been part of another medical investigation.

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 female and between 0 and 20 years old?
Do you have a very serious condition where your immune system is extremely weak?
Do you currently have a widespread CMV infection and a lung infection (pneumonia)?
Are you NOT currently taking high-dose steroids or certain other immune-suppressing medications?
Have you NOT recently been part of another investigational medical treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, the main part of the treatment involves receiving the special donor cells designed to fight the CMV virus. After this treatment, you will have regular check-ups to see how you are doing. While you are in the hospital, these check-ups will happen twice a week until you are well enough to go home.

Once you are discharged, you'll continue to have weekly appointments for the next three months. After that, for the following nine months (until a year after treatment), you'll have monthly visits. Then, for another year (until two years after what's called a planned hematopoietic stem cell transplant, if that's part of the patient's wider treatment), you'll have check-ups every three months. Finally, for a much longer period, up to 15 years, your survival status will be checked every six months.

Potential risks and benefits

Taking part in a study like this could offer a potential benefit by providing a new way to fight a serious CMV infection when other treatments haven't been successful. However, as with any new treatment, there are potential risks, which will be fully explained by the medical team. These could include reactions to the donor cells or other side effects. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Alberta Children's Hospital
Verified postcode
Calgary, Canada

Common questions

What is CMV?

CMV stands for cytomegalovirus. It's a common virus that most people get at some point, often without knowing. But for people with a very weak immune system, it can cause severe and serious health problems.

What does 'profound combined immunodeficiency' mean?

This means a very serious condition where the body's natural defence system (the immune system) is extremely weak and can't effectively fight off infections, making someone very vulnerable to illnesses.

What are 'T lymphocytes'?

T lymphocytes are a type of white blood cell, which are like tiny soldiers in your body's immune system. They are specially trained to find and destroy infected cells, helping to fight off viruses like CMV.

Is this a new medicine?

Yes, this treatment uses special cells from a donor. It's a new approach to help the body fight off serious CMV infections, especially when other treatments haven't worked.

How long will I be followed up after treatment?

The study involves a long follow-up period. You'll have regular checks for up to 15 years to monitor your health and the long-term effects of the treatment.