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NCT Number: NCT07015801

CMV-specific Donor-derived T Lymphocytes 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cytomegalovirus Viremia Cytomegalovirus Pneumonia T-Lymphocyte Immunodeficiency

Age range

0 year–20 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Children's Hospital

Calgary, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMV-VST

Biological

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

Primary outcomes

  1. Feasibility of study

    Time frame: 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.

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Weekly to 3 months

    AEs assessed according to CTCAE grading criteria.

  3. Efficacy of Intervention

    Time frame: Weekly to 3 months

    Change in viremia from baseline according to PCR testing after the intervention

  4. Efficacy of Intervention

    Time frame: Monthly from 3 to 12 months

    Change in viremia from baseline according to PCR testing after the intervention

  5. Efficacy of Intervention

    Time frame: Every 3 months from 12-24 months

    Change in viremia from baseline according to PCR testing after the intervention

Secondary outcomes

  1. Engraftment failure

    Time frame: Enrollment to 24 months

    Assessment of evidence of engraftment failure from clinical evaluations

  2. Graft versus host disease

    Time frame: Enrollment to 24 months

    Assessment of evidence of graft versus host disease (GVHD) from clinical evaluations

  3. Transplant associated thrombotic microangiopathy

    Time frame: Enrollment to 24 months

    Assessment of evidence of Transplant associated thrombotic microangiopathy (TA-TMA) from clinical evaluations

  4. Death

    Time frame: Enrollment to 24 months

    Death of participant

  5. CMV-reactive T cell number

    Time frame: Weekly to 3 months

    The number of CMV-reactive T cells in the patient's blood will be enumerated using an CMV-ELISpot assay.

  6. CMV-reactive T cell number

    Time frame: Monthly from 3 to 12 months

    The number of CMV-reactive T cells in the patient's blood will be enumerated using an CMV-ELISpot assay.

  7. CMV-reactive T cell number

    Time frame: Every 3 months from 12-24 months

    The number of CMV-reactive T cells in the patient's blood will be enumerated using an CMV-ELISpot assay.

  8. Total CMV-reactive T cell activity

    Time frame: Weekly to 3 months

    The total amount of INF γ secreted from all CMV-reactive T cells in the patient's blood to measured using a commercially available ELISA kit (QuantiFERON-CMV). This will allow track the cumulative response to CMV by the reactive T cells over time.

  9. Total CMV-reactive T cell activity

    Time frame: Monthly from 3 to 12 months

    The total amount of INF γ secreted from all CMV-reactive T cells in the patient's blood to measured using a commercially available ELISA kit (QuantiFERON-CMV). This will allow track the cumulative response to CMV by the reactive T cells over time.

  10. Total CMV-reactive T cell activity

    Time frame: Every 3 months from 12-24 months

    The total amount of INF γ secreted from all CMV-reactive T cells in the patient's blood to measured using a commercially available ELISA kit (QuantiFERON-CMV). This will allow track the cumulative response to CMV by the reactive T cells over time.

  11. CMV-reactive T cell phenotyping

    Time frame: Weekly to 3 months

    Flow cytometry will be used to characterize CMV-reactive T cell phenotype

  12. CMV-reactive T cell phenotyping

    Time frame: Monthly from 3 to 12 months

    Flow cytometry will be used to characterize CMV-reactive T cell phenotype

  13. CMV-reactive T cell phenotyping

    Time frame: Every 3 months from 12-24 months

    Flow cytometry will be used to characterize CMV-reactive T cell phenotype

  14. RNA sequencing

    Time frame: Weekly to 3 months

    RNA sequencing, to characterize CMV-reactive T cell biology and track individual VST clones

  15. RNA sequencing

    Time frame: Monthly from 3 to 12 months

    RNA sequencing, to characterize CMV-reactive T cell biology and track individual VST clones

  16. RNA sequencing

    Time frame: Every 3 months from 12-24 months

    RNA sequencing, to characterize CMV-reactive T cell biology and track individual VST clones

  17. Serum cytokine analysis

    Time frame: Weekly to 3 months

    Serum cytokines, to estimate total CMV-reactive T cell activity and host response to treatment

  18. Serum cytokine analysis

    Time frame: Monthly from 3 to 12 months

    Serum cytokines, to estimate total CMV-reactive T cell activity and host response to treatment

  19. Serum cytokine analysis

    Time frame: Every 3 months from 12-24 months

    Serum cytokines, to estimate total CMV-reactive T cell activity and host response to treatment

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Health services
  • Alberta Precision Laboratories
  • University of Alberta

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2040
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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