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

NCT ID: NCT07015801

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2040-04-30

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).

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CMV-specific donor-derived T lymphocytes (CMV-VST).

Mixture of donor lymphocytes, reactive to peptides derived from cytomegalovirus.

Group Type: EXPERIMENTAL

CMV-VST

Intervention Type: BIOLOGICAL

30-40 x 10\^3 viable CD3+ cells/kg

Interventions

CMV-VST

30-40 x 10\^3 viable CD3+ cells/kg

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alberta Precision Laboratories

UNKNOWN

Sponsor Role: collaborator

Alberta Health services

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

CMV-DTL

Identifier Type: -

Identifier Source: org_study_id