CMV-specific Donor-derived T Lymphocytes for the Treatment of Recalcitrant CMV Infection in a Patient With Primary Immunodeficiency
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
Other study identifiers
Sponsor study identifier
interventional
1
1 country
1
Study Start
April 15, 2025
Actual (reported)Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2040
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Brief 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).
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- active not recruiting
- Actual enrollment (reported)
- 1 participants
- Study completion date
April 2040
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Some registry-reported names shown below are not yet linked in this graph.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
April 15, 2025
Actual (reported)First Submitted
May 22, 2025
Actual (reported)First Posted
June 11, 2025
Actual (reported)Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2040
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Last Updated
- June 11, 2025
- Status Verified
- May 2025
- Last Update Submitted
- June 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
Enrollment to 24 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
AEs assessed according to CTCAE grading criteria.
Weekly to 3 months
Efficacy of Intervention
Change in viremia from baseline according to PCR testing after the intervention
Weekly to 3 months
Efficacy of Intervention
Change in viremia from baseline according to PCR testing after the intervention
Monthly from 3 to 12 months
Efficacy of Intervention
Change in viremia from baseline according to PCR testing after the intervention
Every 3 months from 12-24 months
Secondary Outcomes (19)
Engraftment failure
Enrollment to 24 months
Graft versus host disease
Enrollment to 24 months
Transplant associated thrombotic microangiopathy
Enrollment to 24 months
Death
Enrollment to 24 months
CMV-reactive T cell number
Weekly to 3 months
- +14 more secondary outcomes
Study Arms (1)
CMV-specific donor-derived T lymphocytes (CMV-VST).
EXPERIMENTALMixture of donor lymphocytes, reactive to peptides derived from cytomegalovirus.
Interventions
30-40 x 10\^3 viable CD3+ cells/kg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eligibility Criteria
You may qualify if:
- profound combined immunodeficiency
- cytomegalovirus (CMV) infection
- viremia
- pneumonia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alberta Precision LaboratoriesType not reportedcollaborator
- University of CalgaryOtherlead
- Alberta Health servicesOthercollaborator
- University of AlbertaOthercollaborator
Study Sites (1)
Alberta Children's Hospital
Calgary, Alberta, Canada
Enrollment
1 participants (actual enrollment reported by the registry).
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2025
First Posted
June 11, 2025
Study Start
April 15, 2025
Actual (reported)Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2040
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 11, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
- Registry identifier
- NCT07015801
- Data provider
- ClinicalTrials.gov
- Source updated
- 2025-06-11
- Normalization version
- ctgov-legacy-1
Source retrieved: