An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults with Glioblastoma at First Recurrence or Progression (CTMS# 16-0088)
To determine the objective response rate (ORR) per iRANO criteria following intra- and peritumoral infusion using CED of MDNA55 in adult subjects with GB at first recurrence following standard therapy
To assess the safety of MDNA55 following CED in adult subjects with GB at first recurrence following standard therapy.
To assess overall survival (OS) in these subjects
To assess progression-free survival (PFS; using iRANO criteria) in these subjects
To assess the pharmacokinetics (PK) of MDNA55 in peripheral plasma as measured by enzyme-linked immunosorbent assay (ELISA)
To assess anti-MDNA55 antibody titer and, if anti-MDNA55 titer is observed, determine neutralizing antibody titer and its effect on the safety and efficacy of MDNA55
To perform additional ad hoc efficacy and safety analyses as needed based on the data acquired in this study