On July 2 2024 FDA CBER approved the PACT-sponsored Investigational Device Exemption (IDE) application # 30707 named “Allogeneic, TCR αβ and CD19+ cell-depleted peripheral blood mononuclear cells”. Allogeneic BMT patients receiving post-transplant cyclophosphamide to reduce risk of GVHD display impaired innate immunity manifest by an increased risk of viral reactivation. This single center phase I Investigator-Initiated clinical trial led by UW School of Medicine and Public Health BMT section chief Hongtao Liu will examine the safety and efficacy of related-donor day 30 TCR αβ and CD19+ cell-depleted DLI to accelerate innate immune recovery. This milestone was made possible by PACT team effort involving regulatory (Kimberly McDowell), cell manufacturing (Ross Meyers, Olga Ganz, Jessica Murphy) and by support from Hanssens Linda and Michaela Malchow from Miltenyi Biotec. Study activation and patient enrollment is expected in Q1/2025.
Integrated personalized cell technologies for improving health outcomes in children and adults