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

NCT07015801 | Active Not Recruiting

• 1 other identifier: CMV-DTL
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Cytomegalovirus Viremia; Cytomegalovirus Pneumonia; T-Lymphocyte Immunodeficiency

Keywords

donor-derived T lymphocytes

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

Study Arms (1)

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

EXPERIMENTAL

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

Biological: CMV-VST

Interventions

CMV-VST BIOLOGICAL

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

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

Eligibility Criteria

• Age: 0 Years - 20 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Precision Laboratories: collaborator
• Alberta Health services: collaborator
• University of Alberta: collaborator

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

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
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2040
• Last Updated: June 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)