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ACTIVE NOT RECRUITING
NCT03866109
PHASE1/PHASE2

A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT

Sponsor: Genenta Science

View on ClinicalTrials.gov

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.

Official title: A Phase I/IIa Dose Escalation Study Evaluating the Safety and Efficacy of Autologous CD34+-Enriched HSPCs Genetically Modified With Human Interferon-α2 in Patients With Glioblastoma Multiforme and Unmethylated MGMT Gene Promoter

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2019-03-05

Completion Date

2026-06-30

Last Updated

2026-02-09

Healthy Volunteers

No

Interventions

DRUG

Temferon

Genetically modified HSPCs

Locations (3)

Ospedale San Raffaele

Milan, Italy

Fondazione IRCCS Istituto Neurologico "Carlo Besta"

Milan, Italy

Policlinico Universitario Fondazione Agostino Gemelli

Rome, Italy