NCT03330197

A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG

A Phase I/II Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Pediatric Brain Tumor Subjects

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Alaunos Therapeutics · Industry
• Sex: All
• Age: 0 Years – 21 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 in the pediatric population.

Detailed description

Eligible patients will be stratified to one of two arms, according to clinical indication for tumor resection. Pediatric 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. This arm has been completed and is currently closed to enrollment. Pediatric patients with diffuse intrinsic pontine glioma (DIPG) 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

• Pediatric Brain Tumor
• Diffuse Intrinsic Pontine Glioma

Interventions

Type	Name	Description
BIOLOGICAL	Ad-RTS-hIL-12	2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12
DRUG	Oral Veledimex - Arm 1 (Pediatric Brain Tumor)	1 dose level (10mg/day) 15 oral daily doses of veledimex
DRUG	Oral Veledimex - Arm 2 (DIPG)	2 dose levels (10mg/day, 20mg/day) 14 oral daily doses of veledimex

Timeline

• Start date: 2017-09-26
• Primary completion: 2021-09-10
• Completion: 2021-09-10
• First posted: 2017-11-06
• Last updated: 2025-08-12
• Results posted: 2025-08-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study