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Trial of Bi-shRNA-furin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer

NCT01061840 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-03-15

No results posted yet for this study

Summary

Autologous Vigil™ vaccine expresses rhGMCSF and bi-shRNAfurin from the Vigil™ plasmid. The GMCSF protein is a potent stimulator of the immune system, recruiting immune effectors to the site of intradermal injection and promoting antigen presentation. The furin bifunctional shRNA blocks furin protein production at the post transcriptional and translational levels. This decrease in furin in turn decreases the conversion of the proforms TGFβ1 and TGFβ2 proteins. Also, reduced furin protein levels have a negative feedback inhibition on TGFβ1 and TGFβ2 gene expression, decreasing the levels of their mRNAs. The resulting decrease in TGFβ1 and TGFβ2 proteins reduces the local immunosuppression they cause and promotes tumor surface antigen and MHC protein display.

Conditions

Interventions

BIOLOGICAL

Vigil™

Patients will be treated once a month as long as sufficient material is available for up to 12 doses

BIOLOGICAL

Vigil™

Patients will be treated once a month as long as sufficient material is available for up to 12 doses

BIOLOGICAL

Vigil™

Patients will be treated once a month as long as sufficient material is available for up to 12 doses

Sponsors & Collaborators

  • Gradalis, Inc.

    lead INDUSTRY

Principal Investigators

  • Minal Barve, MD · Mary Crowley Cancer Research Centers

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2018-12-06
Completion
2019-01-31

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 NCT01061840 on ClinicalTrials.gov