NCT02026271

A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Glioblastoma or Malignant Glioma

A Phase I Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Subjects With Recurrent or Progressive Glioblastoma or Grade III Malignant Glioma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Alaunos Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of Ad-RTS-hIL-12 given with oral veledimex.

Detailed description

Eligible patients will be stratified to one of two groups, according to clinical indication for tumor resection. Patients who are scheduled for a standard of care craniotomy and tumor resection will receive one dose of veledimex before the resection procedure. Ad-RTS-hIL-12 will be administered by free-hand injection. Patients will continue on oral veledimex for 14 days. Patients not scheduled for tumor resection will receive Ad-RTS-hIL-12 by stereotactic injection and then will continue on oral veledimex for 14 days. The study is divided into three periods: the screening period, the treatment period and the follow-up period.

Conditions

• Glioblastoma Multiforme
• Anaplastic Oligoastrocytoma

Interventions

Type	Name	Description
BIOLOGICAL	Ad-RTS-hIL-12	* 2.0 x 10\^11 viral particles (vp) per injection or 1.0 x 10\^12 viral particles (vp) per injection * one intratumoral injection of Ad-RTS-hIL-12
DRUG	veledimex	* 4 doses (20mg/day, 40mg/day, 80mg/day, and 120mg/day) * 14 oral daily doses of veledimex * 1 Expansion cohort at a single dose level at or below MTD

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2014-01-01
• Last updated: 2025-04-16
• Results posted: 2025-04-16

Locations

6 sites across 1 country: United States