CMV-specific T Cells for CMV Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals with a specific immune system problem and a cytomegalovirus (CMV) infection. The treatment, called CMV-VST, uses special donor cells to combat the virus. It targets those with a severe immune issue who also have CMV in their blood and pneumonia. The trial excludes participants taking certain medications that affect the immune system. As an unphased trial, it provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications, like high doses of steroids, specific immunosuppressants, and checkpoint inhibitors, before participating. If you're on these, you may need to stop them before joining the trial.
What prior data suggests that CMV-specific donor-derived T lymphocytes (CMV-VST) are safe?
Research has shown that using CMV-specific T cells (CMV-VST) to treat cytomegalovirus (CMV) infections is generally safe. Studies have found that these treatments have few side effects. Patients who received CMV-VSTs in various situations experienced minimal side effects, indicating that the treatment is well-tolerated.
In some studies, CMV-VSTs successfully treated patients with hard-to-treat CMV infections. Most patients responded well, and the treatment proved effective and safe. This suggests a low risk of serious side effects, based on the available data.
For those considering joining a trial involving CMV-VSTs, this information indicates that the treatment has a good safety record according to previous research.12345Why are researchers excited about this trial?
Unlike standard treatments for cytomegalovirus (CMV) infections, such as antiviral medications that work to inhibit virus replication, CMV-specific T cells (CMV-VST) offer a unique approach by harnessing the body’s immune system. This treatment uses donor-derived T lymphocytes specifically reactive to CMV peptides, which means it targets the virus more directly and could provide a more precise immune response. Researchers are excited about CMV-VST because it has the potential to offer a targeted, immune-based solution that may be effective even when traditional antivirals are not, and could reduce the risk of resistance developing.
What evidence suggests that CMV-VST might be an effective treatment for CMV infection?
Research has shown that special immune cells, called CMV-specific T cells, hold promise in treating cytomegalovirus (CMV) infections. In this trial, participants will receive CMV-specific donor-derived T lymphocytes (CMV-VST). Studies have found that these cells can help patients respond well to CMV. These T cells effectively reduce the occurrence of CMV, a serious issue for individuals with weakened immune systems. They have also demonstrated minimal side effects, suggesting a potentially safe option. Overall, CMV-specific T cells appear to be a promising way to manage CMV infections, particularly in patients with compromised immune systems.12345
Are You a Good Fit for This Trial?
This trial is for patients with a severe combined immunodeficiency who are struggling with CMV infection and pneumonia. Participants must have persistent viremia despite treatment, indicating a recalcitrant CMV infection.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Treatment of CMV using CMV-specific donor-derived T lymphocytes (CMV-VST) in a patient with profound combined immunodeficiency
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Survival status assessed every 6 months through year 15
What Are the Treatments Tested in This Trial?
Interventions
- CMV-VST
Trial Overview
The study is testing the use of CMV-specific donor-derived T lymphocytes (CMV-VST) to treat stubborn CMV infections in patients whose immune systems are severely compromised.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Mixture of donor lymphocytes, reactive to peptides derived from cytomegalovirus.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Alberta Health services
Collaborator
Alberta Precision Laboratories
Collaborator
University of Alberta
Collaborator
Citations
Virus-Specific T-Cell Therapy for Prophylaxis and Treatment of ...
The CMV infection rate was 28% (interquartile range [IQR], 14%–44%) when CMV-VSTs were used as prophylaxis. Response rates for non–refractory ...
Use of Specific T Lymphocytes in Treating ...
Currently, the best option for treating refractory or resistant CMV is maribavir, with a response rate of around 57% [41]. Therefore, although ...
Multidimensional evaluation of CMV-specific T Cells
Adoptive immunotherapy with CMV-specific T cells (CMV-VSTs) has shown favorable efficacy and minimal adverse effects in clinical settings, ...
T Cell Therapy of Opportunistic Cytomegalovirus Infection
The primary objective of this study is to determine the feasibility of the treatment of opportunistic cytomegalovirus (CMV) infections after hematopoietic stem ...
Cytomegalovirus-specific T cells restricted for shared and ...
The emergence of circulating cytomegalovirus (CMV)- specific T cells correlates with protection from CMV reactivation, an important risk factor for non-relapse ...
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