NCT01822093

Safety Study of ADV-specific T-cells in Paediatric Patients Post Allo-HSCT

Phase I/II Study Investigating the Safety of ADV Specific T Cells in High-risk Paediatric Patients Post Allo-HSCT to Treat ADV Reactivation

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Cell Medica Ltd · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• ADV Infection Post Allo-HSCT

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2013-04-02
• Last updated: 2018-01-25

Locations

3 sites across 1 country: United Kingdom