Frontiers in Immunology (Aug 2024)

First step results from a phase II study of a dendritic cell vaccine in glioblastoma patients (CombiG-vax)

  • Laura Ridolfi,
  • Lorena Gurrieri,
  • Nada Riva,
  • Jenny Bulgarelli,
  • Francesco De Rosa,
  • Massimo Guidoboni,
  • Valentina Fausti,
  • Nicoletta Ranallo,
  • Sebastiano Calpona,
  • Marcella Tazzari,
  • Massimiliano Petrini,
  • Anna Maria Granato,
  • Elena Pancisi,
  • Flavia Foca,
  • Monia Dall’Agata,
  • Isabella Bondi,
  • Elena Amadori,
  • Pietro Cortesi,
  • Chiara Zani,
  • Valentina Ancarani,
  • Alessandro Gamboni,
  • Antonio Polselli,
  • Giuseppe Pasini,
  • Daniela Bartolini,
  • Giuseppe Maimone,
  • Donatella Arpa,
  • Luigino Tosatto

DOI
https://doi.org/10.3389/fimmu.2024.1404861
Journal volume & issue
Vol. 15

Abstract

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BackgroundGlioblastoma (GBM) is a poor prognosis grade 4 glioma. After surgical resection, the standard therapy consists of concurrent radiotherapy (RT) and temozolomide (TMZ) followed by TMZ alone. Our previous data on melanoma patients showed that Dendritic Cell vaccination (DCvax) could increase the amount of intratumoral-activated cytotoxic T lymphocytesMethodsThis is a single-arm, monocentric, phase II trial in two steps according to Simon’s design. The trial aims to evaluate progression-free survival (PFS) at three months and the safety of a DCvax integrated with standard therapy in resected GBM patients. DCvax administration begins after completion of RT-CTwith weekly administrations for 4 weeks, then is alternated monthly with TMZ cycles. The primary endpoints are PFS at three months and safety. One of the secondary objectives is to evaluate the immune response both in vitro and in vivo (DTH skin test).ResultsBy December 2022, the first pre-planned step of the study was concluded with the enrollment, treatment and follow up of 9 evaluable patients. Two patients had progressed within three months after leukapheresis, but none had experienced DCvax-related G3-4 toxicities Five patients experienced a positive DTH test towards KLH and one of these also towards autologous tumor homogenate. The median PFS from leukapheresis was 11.3 months and 12.2 months from surgery.ConclusionsThis combination therapy is well-tolerated, and the two endpoints required for the first step have been achieved. Therefore, the study will proceed to enroll the remaining 19 patients. (Eudract number: 2020-003755-15 https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003755-15/IT)

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