ATT-Heart Trial

Dosage & preparation

Preparation

Other

Highlighted claims

• ATT-Heart is a phase I open-label single-centre dose escalation trial in nine paediatric heart transplant recipients. — Protocol for a phase I single-centre dose escalation trial of autologous thymus derived regulatory T cells in paediatric heart transplant recipients to prevent cardiac allograft vasculopathy (ATT-Heart)
• The trial uses three sequential cohorts of three patients in a single ascending dose design. — Protocol for a phase I single-centre dose escalation trial of autologous thymus derived regulatory T cells in paediatric heart transplant recipients to prevent cardiac allograft vasculopathy (ATT-Heart)
• Each patient receives one 10 mL intravenous dose of TR006 at the bedside after the product is thawed. — Protocol for a phase I single-centre dose escalation trial of autologous thymus derived regulatory T cells in paediatric heart transplant recipients to prevent cardiac allograft vasculopathy (ATT-Heart)
• The trial has no randomisation or blinding because it is designed primarily as a phase I safety study. — Protocol for a phase I single-centre dose escalation trial of autologous thymus derived regulatory T cells in paediatric heart transplant recipients to prevent cardiac allograft vasculopathy (ATT-Heart)
• TR006 is administered 3 to 6 months after transplant to avoid Basiliximab-mediated CD25 blockade and confirm absence of rejection. — Protocol for a phase I single-centre dose escalation trial of autologous thymus derived regulatory T cells in paediatric heart transplant recipients to prevent cardiac allograft vasculopathy (ATT-Heart)