CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Ad-RTS-hIL-12 +1 morebiological
Likely dose
veledimex 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03679754
NCT03679754Phase 1Completed
CompareCT.gov

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

Alaunos Therapeutics·interventional·Posted Sep 20, 2018·Updated Aug 28, 2025

In Brief

A Phase 1 clinical trial evaluating Ad-RTS-hIL-12 and veledimex for Glioblastoma. Completed, enrolled 36 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedSep 20, 2018
Enrollment StartSep 5, 2018
Primary CompletionApr 2, 2019
Study CompletionJan 19, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.8 years ago

Interventions

Ad-RTS-hIL-12biological

* 2.0 x 10\^11 viral particles (vp) per injection * intratumoral injection of Ad-RTS-hIL-12

veledimexdrug

* 20mg/day * 15 oral daily doses of veledimex