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

NCT02026271 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-16

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Alaunos Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jaymes Holland · Alaunos Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02026271 on ClinicalTrials.gov