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| Name | Class |
|---|---|
| Alberta Precision Laboratories | UNKNOWN |
| Alberta Health services | OTHER |
| University of Alberta | OTHER |
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Treatment of CMV in a patient with profound combined immunodeficiency, who has viremia and pneumonia, using CMV-specific donor-derived T lymphocytes (CMV-VST).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMV-specific donor-derived T lymphocytes (CMV-VST). | Experimental | Mixture of donor lymphocytes, reactive to peptides derived from cytomegalovirus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMV-VST | Biological | 30-40 x 10^3 viable CD3+ cells/kg |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment failure | Assessment of evidence of engraftment failure from clinical evaluations | Enrollment to 24 months |
| Graft versus host disease | Assessment of evidence of graft versus host disease (GVHD) from clinical evaluations |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Calgary | Alberta | Canada |
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| Enrollment to 24 months |
| Transplant associated thrombotic microangiopathy | Assessment of evidence of Transplant associated thrombotic microangiopathy (TA-TMA) from clinical evaluations | Enrollment to 24 months |
| Death | Death of participant | Enrollment to 24 months |
| CMV-reactive T cell number | The number of CMV-reactive T cells in the patient's blood will be enumerated using an CMV-ELISpot assay. | Weekly to 3 months |
| CMV-reactive T cell number | The number of CMV-reactive T cells in the patient's blood will be enumerated using an CMV-ELISpot assay. | Monthly from 3 to 12 months |
| CMV-reactive T cell number | The number of CMV-reactive T cells in the patient's blood will be enumerated using an CMV-ELISpot assay. | Every 3 months from 12-24 months |
| Total CMV-reactive T cell activity | 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. | Weekly to 3 months |
| Total CMV-reactive T cell activity | 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. | Monthly from 3 to 12 months |
| Total CMV-reactive T cell activity | 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. | Every 3 months from 12-24 months |
| CMV-reactive T cell phenotyping | Flow cytometry will be used to characterize CMV-reactive T cell phenotype | Weekly to 3 months |
| CMV-reactive T cell phenotyping | Flow cytometry will be used to characterize CMV-reactive T cell phenotype | Monthly from 3 to 12 months |
| CMV-reactive T cell phenotyping | Flow cytometry will be used to characterize CMV-reactive T cell phenotype | Every 3 months from 12-24 months |
| RNA sequencing | RNA sequencing, to characterize CMV-reactive T cell biology and track individual VST clones | Weekly to 3 months |
| RNA sequencing | RNA sequencing, to characterize CMV-reactive T cell biology and track individual VST clones | Monthly from 3 to 12 months |
| RNA sequencing | RNA sequencing, to characterize CMV-reactive T cell biology and track individual VST clones | Every 3 months from 12-24 months |
| Serum cytokine analysis | Serum cytokines, to estimate total CMV-reactive T cell activity and host response to treatment | Weekly to 3 months |
| Serum cytokine analysis | Serum cytokines, to estimate total CMV-reactive T cell activity and host response to treatment | Monthly from 3 to 12 months |
| Serum cytokine analysis | Serum cytokines, to estimate total CMV-reactive T cell activity and host response to treatment | Every 3 months from 12-24 months |