ASH 2020 | First-in-human trial of rapidly manufactured UltraCAR T-cells in R/R myeloid malignancies
David Sallman, MD, Moffitt Cancer Center, Tampa, FL, outlines the design of a Phase I/Ib first-in-human trial (NCT03927261) of CD33-targeted PRGN-3006 UltraCAR-T cells in relapsed/refractory (R/R) acute myeloid leukemia (AML), hypomethylating agent-failure higher-risk myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia. Current CAR T-cell therapies have long manufacturing and expansion periods, setting back treatment in a rapidly progressing disease. The UltraCAR-T platform uses a non-viral gene delivery system and a rapid manufacturing process that allows overnight production with no ex vivo expansion requirement. As well as CD33-CAR, PRGN-3006 UltraCAR T-cells express membrane bound IL-15, shown preclinically to cause a maintained stem-like memory phenotype. Two cohorts will be enrolled to receive the treatment using a dose-escalation design, with or without prior lymphodepletion. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.
Disclosures
Advisory board: AbbVie, Agios, Aprea, BMS, Celyad, Gilead, Intellia, Kite, Novartis, Syndax
Speaker’s bureau: Agios, BMS, Incyte
Consultant: Magenta
Research funding: Celgene, Jazz
