Author:
Heinz Amadeus T,Calkoen Friso G.J.,Derbich Alexander,Miltner Lea,Seitz Christian,Doering Michaela,Braun Christiane,Atar Daniel,Schumm Michael,Heubach Florian,Arendt Anne-Marie,Schulz Ansgar,Schuster Friedhelm R,Meisel Roland,Strahm Brigitte,Finke Juergen,Heineking Beatrice,Stetter Susanne,Silling Gerda,Stachel Daniel,Gruhn Bernd,Debatin Klaus-Michael,Foell Juergen,Schulte Johannes H,Woessmann Wilhelm,Mauz-Körholz Christine,Tischer Johanna,Feuchtinger Tobias,Handgretinger Rupert,Lang Peter
Abstract
Therapy-resistant viral reactivations contribute significantly to mortality after hematopoietic stem cell transplantation. Adoptive cellular therapy with virus-specific T cells (VST) has shown efficacy in various single-center trials. However, the scalability of this therapy is hampered by laborious production methods. In this study we describe the in-house production of VST in a closed system (CliniMACS Prodigy® system, Miltenyi Biotec). In addition, we report the efficacy in 26 patients with viral disease following hematopoietic stem cell transplantation in a retrospective analysis (adenovirus, n=7; cytomegalovirus, n=8; Epstein-Barr virus, n=4; multi-viral, n=7). The production of VST was successful in 100% of cases. The safety profile of VST therapy was favorable (n=2 grade 3 and n=1 grade 4 adverse events; all three were reversible). A response was seen in 20 of 26 patients (77%). Responding patients had a significantly better overall survival than patients who did not respond (P<0.001). Virus-specific symptoms were reduced or resolved in 47% of patients. The overall survival of the whole cohort was 28% after 6 months. This study shows the feasibility of automated VST production and safety of application. The scalability of the CliniMACS Prodigy® device increases the accessibility of VST treatment.
Publisher
Ferrata Storti Foundation (Haematologica)
Cited by
2 articles.
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