Cytomegalovirus ViremiaNCT07015801
CMV-specific Donor-derived T Lymphocytes for the Treatment of Recalcitrant CMV Infection in a Patient With Primary Immunodeficiency
A study testing CMV-VST in people with Cytomegalovirus Viremia and Cytomegalovirus Pneumonia, run by University of Calgary at 1 site in Canada.
Trial summary
Treatment of CMV in a patient with profound combined immunodeficiency, who has viremia and pneumonia, using CMV-specific donor-derived T lymphocytes (CMV-VST). Read more about this study
- Who is it for?
- Ages 0 to 20 years, women only
- Conditions the study is for
- Cytomegalovirus Viremia, Cytomegalovirus Pneumonia, T-Lymphocyte Immunodeficiency
- What is being tested?
- CMV-VST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2025to Apr 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 20 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- profound combined immunodeficiency
- cytomegalovirus (CMV) infection
- viremia
- pneumonia
Who cannot join
- Receiving a steroid dose of ≥ 0.5 mg/kg of prednisolone equivalent
- Receiving antithymocyte globulin or similar anti-T-cell antibody therapy, methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells, and extracorporeal
- Receiving checkpoint inhibitor agents (eg, nivolumab, pembrolizumab, ipilimumab) are within 3 drug half-lives of the most recent dose to cycle 1 day 1.
- Administration of another investigational product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Individual Patient Study of Cytomegalovirus (CMV)-Specific Donor-derived T Lymphocytes (DTL) for the Treatment of Recalcitrant CMV Infection in a Patient With Primary Immunodeficiency
Treatment of CMV in a patient with profound combined immunodeficiency, who has viremia and pneumonia, using CMV-specific donor-derived T lymphocytes (CMV-VST).
Read the detailed description
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.
- Being tested
- CMV-VST
- Keywords
- donor-derived T lymphocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV-VSTBiological
30-40 x 10^3 viable CD3+ cells/kg
| Study group | Role | What they receive |
|---|---|---|
| CMV-specific donor-derived T lymphocytes (CMV-VST). | Experimental | Mixture of donor lymphocytes, reactive to peptides derived from cytomegalovirus. Receives: Biological: CMV-VST |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment to 24 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
AEs assessed according to CTCAE grading criteria.
Measured: Weekly to 3 months
Efficacy of Intervention
Change in viremia from baseline according to PCR testing after the intervention
Measured: Weekly to 3 months
Efficacy of Intervention
Change in viremia from baseline according to PCR testing after the intervention
Measured: Monthly from 3 to 12 months
Efficacy of Intervention
Change in viremia from baseline according to PCR testing after the intervention
Measured: Every 3 months from 12-24 months
Secondary outcomes (19)
Engraftment failure
Assessment of evidence of engraftment failure from clinical evaluations
Measured: Enrollment to 24 months
Graft versus host disease
Assessment of evidence of graft versus host disease (GVHD) from clinical evaluations
Measured: Enrollment to 24 months
Transplant associated thrombotic microangiopathy
Assessment of evidence of Transplant associated thrombotic microangiopathy (TA-TMA) from clinical evaluations
Measured: Enrollment to 24 months
Death
Death of participant
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Every 3 months from 12-24 months
CMV-reactive T cell phenotyping
Flow cytometry will be used to characterize CMV-reactive T cell phenotype
Measured: Weekly to 3 months
CMV-reactive T cell phenotyping
Flow cytometry will be used to characterize CMV-reactive T cell phenotype
Measured: Monthly from 3 to 12 months
CMV-reactive T cell phenotyping
Flow cytometry will be used to characterize CMV-reactive T cell phenotype
Measured: Every 3 months from 12-24 months
RNA sequencing
RNA sequencing, to characterize CMV-reactive T cell biology and track individual VST clones
Measured: Weekly to 3 months
RNA sequencing
RNA sequencing, to characterize CMV-reactive T cell biology and track individual VST clones
Measured: Monthly from 3 to 12 months
RNA sequencing
RNA sequencing, to characterize CMV-reactive T cell biology and track individual VST clones
Measured: 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
Measured: Weekly to 3 months
Serum cytokine analysis
Serum cytokines, to estimate total CMV-reactive T cell activity and host response to treatment
Measured: Monthly from 3 to 12 months
Serum cytokine analysis
Serum cytokines, to estimate total CMV-reactive T cell activity and host response to treatment
Measured: Every 3 months from 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start15 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus ViremiaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Precision Laboratories, Alberta Health services, University of Alberta
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015801
- Sponsor's protocol ID
- CMV-DTL
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Individual Patient Study of Cytomegalovirus (CMV)-Specific Donor-derived T Lymphocytes (DTL) for the Treatment of Recalcitrant CMV Infection in a Patient With Primary Immunodeficiency
- ClinicalTrials.gov ID
- NCT07015801
- Acronym / sponsor ID
- CMV-DTL
- Keywords
- donor-derived T lymphocytes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Precision Laboratories, Alberta Health services, University of Alberta
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2040 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of CMV in a patient with profound combined immunodeficiency, who has viremia and pneumonia, using CMV-specific donor-derived T lymphocytes (CMV-VST).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMV-specific donor-derived T lymphocytes (CMV-VST). | Experimental | Biological: CMV-VSTMixture of donor lymphocytes, reactive to peptides derived from cytomegalovirus. |
Who may qualify
- Ages
- 0 to 20 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- profound combined immunodeficiency
- cytomegalovirus (CMV) infection
- viremia
- pneumonia
Key exclusion criteria (4 listed)
- Receiving a steroid dose of ≥ 0.5 mg/kg of prednisolone equivalent
- Receiving antithymocyte globulin or similar anti-T-cell antibody therapy, methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells, and extracorporeal
- Receiving checkpoint inhibitor agents (eg, nivolumab, pembrolizumab, ipilimumab) are within 3 drug half-lives of the most recent dose to cycle 1 day 1.
- Administration of another investigational product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMV-VST30-40 x 10^3 viable CD3+ cells/kg | Biological | CMV-specific donor-derived T lymphocytes (CMV-VST). |
Primary outcome
Feasibility of study
Time frame: Enrollment to 24 months
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.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Weekly to 3 months
AEs assessed according to CTCAE grading criteria.
Efficacy of Intervention
Time frame: Weekly to 3 months
Change in viremia from baseline according to PCR testing after the intervention
Efficacy of Intervention
Time frame: Monthly from 3 to 12 months
Change in viremia from baseline according to PCR testing after the intervention
Efficacy of Intervention
Time frame: Every 3 months from 12-24 months
Change in viremia from baseline according to PCR testing after the intervention
19 secondary outcomes
Engraftment failure
Time frame: Enrollment to 24 months
Graft versus host disease
Time frame: Enrollment to 24 months
Transplant associated thrombotic microangiopathy
Time frame: Enrollment to 24 months
Death
Time frame: Enrollment to 24 months
CMV-reactive T cell number
Time frame: Weekly to 3 months
CMV-reactive T cell number
Time frame: Monthly from 3 to 12 months
CMV-reactive T cell number
Time frame: Every 3 months from 12-24 months
Total CMV-reactive T cell activity
Time frame: Weekly to 3 months
Total CMV-reactive T cell activity
Time frame: Monthly from 3 to 12 months
Total CMV-reactive T cell activity
Time frame: Every 3 months from 12-24 months
CMV-reactive T cell phenotyping
Time frame: Weekly to 3 months
CMV-reactive T cell phenotyping
Time frame: Monthly from 3 to 12 months
CMV-reactive T cell phenotyping
Time frame: Every 3 months from 12-24 months
RNA sequencing
Time frame: Weekly to 3 months
RNA sequencing
Time frame: Monthly from 3 to 12 months
RNA sequencing
Time frame: Every 3 months from 12-24 months
Serum cytokine analysis
Time frame: Weekly to 3 months
Serum cytokine analysis
Time frame: Monthly from 3 to 12 months
Serum cytokine analysis
Time frame: Every 3 months from 12-24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMV-VST in people with Cytomegalovirus Viremia and Cytomegalovirus Pneumonia, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study (time frame: Enrollment to 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.