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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).
Details
| Lead sponsor | University of Calgary |
|---|---|
| Phase | NA |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 1 |
| Start date | 2025-04-15 |
| Completion | 2040-04 |
Conditions
- Cytomegalovirus Viremia
- Cytomegalovirus Pneumonia
- T-Lymphocyte Immunodeficiency
Interventions
- CMV-VST
Primary outcomes
- Feasibility of study — 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] — Weekly to 3 months
AEs assessed according to CTCAE grading criteria. - Efficacy of Intervention — Weekly to 3 months
Change in viremia from baseline according to PCR testing after the intervention - Efficacy of Intervention — Monthly from 3 to 12 months
Change in viremia from baseline according to PCR testing after the intervention - Efficacy of Intervention — Every 3 months from 12-24 months
Change in viremia from baseline according to PCR testing after the intervention
Countries
Canada