CMV-specific Donor-derived T Lymphocytes for the Treatment of Recalcitrant CMV Infection in a Patient With Primary Immunodeficiency

University of Calgary

Status

Active, not recruiting

Conditions

T-Lymphocyte Immunodeficiency

Cytomegalovirus Pneumonia

Cytomegalovirus Viremia

Treatments

Biological: CMV-VST

Study type

Interventional

Funder types

Other

Identifiers

NCT07015801

CMV-DTL

Details and patient eligibility

About

Treatment of CMV in a patient with profound combined immunodeficiency, who has viremia and pneumonia, using CMV-specific donor-derived T lymphocytes (CMV-VST).

Full 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.

Enrollment

1 patient

Sex

Female

Ages

Under 20 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

profound combined immunodeficiency
cytomegalovirus (CMV) infection
viremia
pneumonia

Exclusion criteria

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