NCT07015801

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: Female
• Age: 0 Years – 20 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Cytomegalovirus Viremia
• Cytomegalovirus Pneumonia
• T-Lymphocyte Immunodeficiency

Interventions

Type	Name	Description
BIOLOGICAL	CMV-VST	30-40 x 10\^3 viable CD3+ cells/kg

Timeline

• Start date: 2025-04-15
• Primary completion: 2027-04-01
• Completion: 2040-04-01
• First posted: 2025-06-11
• Last updated: 2025-06-11

Locations

1 site across 1 country: Canada