An interventional study of CMV-VST in Cytomegalovirus Viremia, Cytomegalovirus Pneumonia and T-Lymphocyte Immunodeficiency, sponsored by University of Calgary. Active, not recruiting at 1 site in Canada. Open to female participants aged 0 Years to 20 Years. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by University of Calgary · Not applicable, Interventional, and Treatment
Treatment of CMV in a patient with profound combined immunodeficiency, who has viremia and pneumonia, using CMV-specific donor-derived T lymphocytes (CMV-VST).
Treatment of CMV in a patient with profound combined immunodeficiency, who has viremia and pneumonia, using CMV-specific donor-derived T lymphocytes (CMV-VST), a cell therapy product containing a mixture of donor lymphocytes, reactive to peptides derived from cytomegalovirus.
After having receipt of therapy, the patient will have clinical assessments twice a week until discharge from the inpatient unit. After discharge, assessments will be performed on a weekly basis for three months. From 3-12 months, the patient will be seen monthly and then every three months till 2 years post planned hematopoietic stem cell transplantation. After 2 years, survival status will be assessed every 6 months through year 15.
1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.
This study's enrollment of 1 is below the median of 129 across 975 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mixture of donor lymphocytes, reactive to peptides derived from cytomegalovirus.
Biological: CMV-VST
30-40 x 10\^3 viable CD3+ cells/kg
Feasibility of study
Evaluate the feasibility of conducting this study, evaluated in terms of whether or not the study could be completed as laid out in the protocol in the time allotted.
Time frame: Enrollment to 24 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
AEs assessed according to CTCAE grading criteria.
Time frame: Weekly to 3 months
Efficacy of Intervention
Change in viremia from baseline according to PCR testing after the intervention
Time frame: Weekly to 3 months
Efficacy of Intervention
Change in viremia from baseline according to PCR testing after the intervention
Time frame: Monthly from 3 to 12 months
Efficacy of Intervention
Change in viremia from baseline according to PCR testing after the intervention
Time frame: Every 3 months from 12-24 months
Engraftment failure
Assessment of evidence of engraftment failure from clinical evaluations
Time frame: Enrollment to 24 months
Graft versus host disease
Assessment of evidence of graft versus host disease (GVHD) from clinical evaluations
Time frame: Enrollment to 24 months
Transplant associated thrombotic microangiopathy
Assessment of evidence of Transplant associated thrombotic microangiopathy (TA-TMA) from clinical evaluations
Time frame: Enrollment to 24 months
Death
Death of participant
Time frame: Enrollment to 24 months
CMV-reactive T cell number
The number of CMV-reactive T cells in the patient's blood will be enumerated using an CMV-ELISpot assay.
Time frame: Weekly to 3 months
CMV-reactive T cell number
The number of CMV-reactive T cells in the patient's blood will be enumerated using an CMV-ELISpot assay.
Time frame: Monthly from 3 to 12 months
CMV-reactive T cell number
The number of CMV-reactive T cells in the patient's blood will be enumerated using an CMV-ELISpot assay.
Time frame: Every 3 months from 12-24 months
Total CMV-reactive T cell activity
The total amount of INF γ secreted from all CMV-reactive T cells in the patient's blood to measured using a commercially available ELISA kit (QuantiFERON-CMV). This will allow track the cumulative response to CMV by the reactive T cells over time.
Time frame: Weekly to 3 months
Total CMV-reactive T cell activity
The total amount of INF γ secreted from all CMV-reactive T cells in the patient's blood to measured using a commercially available ELISA kit (QuantiFERON-CMV). This will allow track the cumulative response to CMV by the reactive T cells over time.
Time frame: Monthly from 3 to 12 months
Total CMV-reactive T cell activity
The total amount of INF γ secreted from all CMV-reactive T cells in the patient's blood to measured using a commercially available ELISA kit (QuantiFERON-CMV). This will allow track the cumulative response to CMV by the reactive T cells over time.
Time frame: Every 3 months from 12-24 months
CMV-reactive T cell phenotyping
Flow cytometry will be used to characterize CMV-reactive T cell phenotype
Time frame: Weekly to 3 months
CMV-reactive T cell phenotyping
Flow cytometry will be used to characterize CMV-reactive T cell phenotype
Time frame: Monthly from 3 to 12 months
CMV-reactive T cell phenotyping
Flow cytometry will be used to characterize CMV-reactive T cell phenotype
Time frame: Every 3 months from 12-24 months
RNA sequencing
RNA sequencing, to characterize CMV-reactive T cell biology and track individual VST clones
Time frame: Weekly to 3 months
RNA sequencing
RNA sequencing, to characterize CMV-reactive T cell biology and track individual VST clones
Time frame: Monthly from 3 to 12 months
RNA sequencing
RNA sequencing, to characterize CMV-reactive T cell biology and track individual VST clones
Time frame: Every 3 months from 12-24 months
Serum cytokine analysis
Serum cytokines, to estimate total CMV-reactive T cell activity and host response to treatment
Time frame: Weekly to 3 months
Serum cytokine analysis
Serum cytokines, to estimate total CMV-reactive T cell activity and host response to treatment
Time frame: Monthly from 3 to 12 months
Serum cytokine analysis
Serum cytokines, to estimate total CMV-reactive T cell activity and host response to treatment
Time frame: Every 3 months from 12-24 months
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Apr 2027, 24 months after the start.
Of 258 non-industry interventional studies with no phase under Pneumonia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's planned 24 months is above that.
Counting every sponsor, half of 265 studies reached it within 21 months; a quarter within 10 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.