NCT03679754

Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102

Protocol ATI001-102 Expansion Substudy: Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (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 intratumoral injection of Ad-RTS-hIL-12 given with oral veledimex.

Detailed description

Patients who are scheduled for 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. The study is divided into three periods: the screening period, the treatment period and the follow-up period.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
BIOLOGICAL	Ad-RTS-hIL-12	* 2.0 x 10\^11 viral particles (vp) per injection * intratumoral injection of Ad-RTS-hIL-12
DRUG	veledimex	* 20mg/day * 15 oral daily doses of veledimex

Timeline

• Start date: 2018-09-05
• Primary completion: 2019-04-02
• Completion: 2021-01-19
• First posted: 2018-09-20
• Last updated: 2025-08-28
• Results posted: 2025-08-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study