Automated production of specific T cells for treatment of refractory viral infections after allogeneic stem cell transplantation.

Therapy resistant viral reactivations significantly contribute to mortality after hematopoietic stem cell transplantation. Adoptive cellular therapy with virus-specific T cells has shown efficacy in various single center trials. However, scalability of this therapy is hampered by laborious production methods. In this study we describe the in-house production of virus-specific T cells (VST) in a closed system (CliniMACS Prodigy® system by Miltenyi Biotec). In addition, we report the efficacy in 26 patients with viral disease post HSCT in a retrospective analysis (ADV n=7, CMV n=8, EBV n=4, multi-viral n=7). Production of VST was successful in 100% of cases. Safety profile of VST therapy was favorable (n=2 adverse event grade 3, n=1 grade 4; all three were reversible). A response was seen in 20 of 26 patients (77%). Responding patients had a significantly better OS than patients without response (p.