Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies

Fludarabine is an antimetabolite given prior to lymphodepletion.

Cyclophosphamide is a nitrogen mustard-derivative, polyfunctional alkylating agent given prior to lymphodepletion.

PRGN-3007 T cells are autologous T cells that are genetically modified ex vivo with the Sleeping Beauty (SB) system to express a ROR1-specific chimeric antigen receptor (ROR1 CAR), membrane bound interleukin-15 (mbIL15), a kill switch derived from truncated form of human epidermal growth factor receptor (HER1t) and include a built-in mechanism for intrinsic downregulation of programmed cell death receptor 1 (PD-1) expression on UltraCAR-T cells.The transgenes are delivered from a SB transposon which ensures co-expression all transgenes in all transfected cells. T cells are selected from the apheresis product and can be modified with the SB system to manufacture the T cells with the potential of infusing within 2 days from genetic modification.