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| Name | Class |
|---|---|
| Technology Strategy Board, United Kingdom | OTHER |
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Human Adenovirus-specific T-cells can persist and augment impaired adenovirus immune response post allogeneic haematopoietic stem cell transplant, and reduce the requirement for antiviral therapy without toxicity or increasing the occurrence of Graft Versus Host Disease. This is a Phase I/IIa open-label safety study, assessing the effects of administering adenovirus-specific T-cells (Cytovir ADV) to paediatric patients post haematopoietic stem cell transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cytovir-ADV | Experimental | Adenovirus-specific T-cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytovir-ADV | Biological | A single dose 1x10e4 CD3+ T cells/kg patient weight of Cytovir ADV is prescribed to patients on exhibiting two consecutive PCR positive Adenovirus viraemia results > 1000 copies/ml. Patients are followed up by continued monitoring of Adenovirus viraemia results. If patients exhibit uncontrolled ADV viraemia at ≥ 4 weeks following the first cell dose, they will be prescribed a second cell dose of 10e5 CD3+ T cell/kg. Patients will be monitored for 6 months following infusion of Cytovir ADV. This is a feasibility/pilot study and has no control group |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with new onset GVHD | 180 days | |
| number of subjects developing NCI Grade 3-4 adverse events | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of reported Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Suspected Expected Serious Adverse Reactions (SESARs) | 180 days | |
| Number of detectable HAdV-specific T-cells in vivo at each time point | 180 days |
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Inclusion Criteria:
Patients:
Donors
Exclusion Criteria:
Patients
Donors
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| Name | Affiliation | Role |
|---|---|---|
| Waseem Qasim | Institute of Child Health, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Ormond Street Hospital | London | United Kingdom | ||||
| Royal Manchester Children's Hospital |
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| Requirement for second infusion of HAdV-specific T-cells | 180 days |
| Number of treatment days with antiviral drugs | 180 days |
| Number of treatment days with other anti-infective drugs | 180 days |
| Number of in-hospital days during 6 month post-infusion period | 180 days |
| Manchester |
| United Kingdom |
| Royal Victoria Infirmary | Newcastle | United Kingdom |