A Phase 1/2 interventional study of Cytovir-ADV in ADV Infection Post Allo-HSCT, sponsored by Cell Medica Ltd. Completed at 3 sites in United Kingdom. Open to participants aged Up to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-25.
Sponsored by Cell Medica Ltd · Phase 1/2, Interventional, and Treatment
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.
104 studies on the registry are indexed under Adenoviridae Infections; 32 are open to participants now.
This study's enrollment of 8 is below the median of 36 across 80 interventional studies indexed under Adenoviridae Infections.
Browse Adenoviridae Infections studies →Cell Medica Ltd is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients:
Donors
Exclusion Criteria:
Patients
Donors
Adenovirus-specific T-cells
Biological: Cytovir-ADV
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
Also known as: Adenovirus-specific T-cells
Number of subjects with new onset GVHD
Time frame: 180 days
number of subjects developing NCI Grade 3-4 adverse events
Time frame: 180 days
Number of reported Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Suspected Expected Serious Adverse Reactions (SESARs)
Time frame: 180 days
Number of detectable HAdV-specific T-cells in vivo at each time point
Time frame: 180 days
Requirement for second infusion of HAdV-specific T-cells
Time frame: 180 days
Number of treatment days with antiviral drugs
Time frame: 180 days
Number of treatment days with other anti-infective drugs
Time frame: 180 days
Number of in-hospital days during 6 month post-infusion period
Time frame: 180 days
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cell Medica Ltd