A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT

Summary

This is a non-randomized, open label, phase I/IIa, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector driving myeloid specific interferon-alpha2 expression, which will be administered to up to 27 patients affected by GBM who have an unmethylated MGMT promoter. Part A will evaluate the safety and tolerability of 5 escalating doses of Temferon and 3 different conditioning regimens in up to 27 patients, following first line treatment.

Timeline

Start

2019-03-05

Primary completion

2026-05-27

Completion

2026-05-27

Publications

• Gentner B, Eoli M, Farina F, Barcella M, Capotondo A, Mazzoleni S, Brambilla V, Francavilla A, Garramone M, Carrabba MG, Ferla V, Bruno A, Alvisi G, Coltella N, Montini E, Hadadi L, Capt C, Cuccarini V, Bruzzone MG, Di Meco F, Legnani FG, Ferroli P, Acerbi F, Pallini R, D'Alessandris QG, Olivi A, Gagliardi F, Snider S, Mortini P, Patane M, Fiocchi A, Berno V, Poliani PL, Finocchiaro G, Russo C, Ciceri F, Naldini L. Tumor-targeted interferon-alpha gene therapy for glioblastoma: a phase 1 trial. Nat Med. 2026 Jun;32(6):2216-2226. doi: 10.1038/s41591-026-04419-1. Epub 2026 Jun 1.

Drugs

Indications