Autologous Cell Immunotherapy (IGV-001) with IGF-1R Antisense Oligonucleotide in Newly Diagnosed Glioblastoma Patients
Ian Lee, Simon Hanft, Michael Schulder, Kevin Judy, Eric T. Wong, J. Bradley Elder, Linton T. Evans, Mario Zuccarello, Julian K. Wu, Sonikpreet Aulakh, Vijay Agarwal, Rohan Ramakrishna, Brian Gill, Alfredo Quiñones‐Hinojosa, Cameron Brennan, Brad E. Zacharia, Carlos Eduardo Silva Correia, Madhavi Diwanji, Gregory Pennock, Charles Scott, Raül Pérez‐Ollé, David W. Andrews, John A. Boockvar
Abstract
Standard-of-care first-line therapy for patients with newly diagnosed glioblastoma (ndGBM) is maximal safe surgical resection, then concurrent radiotherapy and temozolomide, followed by maintenance temozolomide. IGV-001, the first product of the Goldspire™ platform, is a first-in-class autologous immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers, with the intent to induce a tumor-specific immune response in patients with ndGBM. Here, we describe the design and rationale of a randomized, double-blind, phase IIb trial evaluating IGV-001 compared with placebo, both followed by standard-of-care treatment in patients with ndGBM. The primary end point is progression-free survival, and key secondary end points include overall survival and safety.