AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A multicenter, open-label, dose-escalation clinical trial to evaluate the safety of viral-specific T-cell (VST) therapy in the treatment of refractory viral infections after allogeneic hematopoietic stem cell transplantation (ALLOVISTA).

This is an early-stage clinical trial (Phase I) exploring a new treatment for serious viral infections, specifically Cytomegalovirus (CMV), that don't respond to usual medicines. These infections can happen in adults after they've had a special type of bone marrow transplant, called an allogeneic hematopoietic stem cell transplant. The new treatment uses special cells called viral-specific T-cells (VST). The main goal of this study is to check how safe this VST therapy is in people and to figure out what the best dose might be. It's an 'open-label' study, meaning both patients and their doctors will know what treatment is being given.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Wroclaw Medical University

Enrolment target

Start

22 Apr 2025

Resistant viral infections caused by cytomegalovirus (CMV) in adult patients after allogeneic hematopoietic stem cell transplantation.

What is this study about?

You're probably reading this because you, or someone you care about, is facing a very challenging situation: a serious viral infection after a bone marrow transplant that isn't getting better with standard treatments. These infections, like Cytomegalovirus (CMV), can be very tough to treat because the immune system is often weakened after such a complex procedure. This particular study, called ALLOVISTA, is looking into a new way to fight these stubborn viruses.

The study is investigating something called 'viral-specific T-cell therapy,' or VST for short. T-cells are a really important part of our immune system, like tiny soldiers that fight off invaders. In this therapy, special T-cells are designed or selected to specifically target and kill cells infected with the virus. The idea is to boost your body's own ability to fight off the infection when other medicines haven't worked.

Because this is a Phase I study, it's one of the first times this specific VST therapy is being given to people. This means the main focus is on safety — making sure the treatment doesn't cause unexpected or severe side effects. Researchers will also be carefully looking at different doses of the therapy to find the amount that is both safe and potentially effective. They want to see if these VST cells can help clear the infection in patients who have exhausted other treatment options.

Key takeaways

This study is for adults with severe, hard-to-treat CMV infections after a bone marrow transplant.
It's testing a new immune cell therapy called VST.
The main goal is to check the safety of the new treatment and find the right dose.
This is an early-stage study (Phase I).
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

This study is looking for adults who are at least 18 years old. There's no upper age limit mentioned. Participants must have a specific type of viral infection that hasn't responded to other treatments.

Specifically, you would need to have a serious Cytomegalovirus (CMV) infection that is resistant to standard antiviral medications. This infection must have happened after you received a bone marrow transplant from another person (known as an allogeneic hematopoietic stem cell transplant).

If you're an adult who has had this type of bone marrow transplant and are now struggling with a hard-to-treat CMV infection, you might be someone they are looking for. Both men and women can take part. Doctors involved in the study will check many other factors to see if this study is right for you, but these are the main starting points.

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 had a bone marrow transplant from another person (not your own cells)?
Do you have a Cytomegalovirus (CMV) infection that hasn't responded to standard medicines?
Are you an adult with this specific type of viral infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the VST therapy. Since this is a dose-escalation study, the amount of VST cells you receive might be different from other participants, as the researchers aim to find the safest and most effective dose. The treatment will involve receiving these special cells, likely through an infusion, similar to a drip.

Throughout the study, you would have regular visits to the hospital or clinic. These visits will involve various assessments, such as blood tests, physical examinations, and possibly other tests to monitor the viral infection and check for any side effects. The exact number and frequency of visits, as well as the total duration of your participation, would be explained in detail by the study team. This would include follow-up appointments after receiving the treatment to ensure your safety and monitor your health over time.

Potential risks and benefits

Participating in any clinical trial involves potential benefits and risks. A potential benefit of this study is that you might receive a new treatment for your severe viral infection when other options haven't worked, which could help your body fight off the virus. However, since this is a new therapy, there are unknown risks, and you might experience side effects that are not yet fully understood. There's also no guarantee that the treatment will be effective for your infection. It's very important to remember that 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
Poland

Common questions

What is a 'viral-specific T-cell' (VST) therapy?

VST therapy uses special immune cells trained to find and destroy cells infected with a specific virus, like CMV. It's like giving your body extra 'soldiers' to fight the infection.

What does 'refractory' viral infection mean?

This means the viral infection is serious and hasn't gotten better with the usual medicines and treatments that doctors normally use.

What is an 'allogeneic hematopoietic stem cell transplant'?

This is a type of bone marrow transplant where you receive healthy stem cells from another person (a donor), rather than your own cells.

What does 'Phase I' mean for a study?

Phase I is the earliest stage of human testing for a new treatment. The main goals are to check if it's safe and to find the right dose, rather than to prove it cures the disease.

Will I know if I'm getting the VST therapy?

Yes, this is an 'open-label' study. This means both you and your study doctor will know that you are receiving the VST therapy.