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Trial record 12 of 13 for:    22186789 [PUBMED-IDS] AND intradermal

Expanded Access of Vigil in Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03842865
Expanded Access Status : Available
First Posted : February 15, 2019
Last Update Posted : March 20, 2019
Information provided by (Responsible Party):
Gradalis, Inc.

Tracking Information
First Submitted Date February 13, 2019
First Posted Date February 15, 2019
Last Update Posted Date March 20, 2019
Descriptive Information
Brief Title Expanded Access of Vigil in Solid Tumors
Brief Summary This is a multicenter, expanded access protocol of intradermal autologous Vigil immunotherapy. Subjects meeting expanded access eligibility criteria will receive a minimum of 1 immunotherapy dose of Vigil (1 x 10e4, 1 x 10e5, or 1 x 10e6 cells/injection), intradermally every 4 weeks as monotherapy.
Detailed Description

Approximately 40 subjects who had tissue procured and Vigil manufactured but fail manufacturing release criteria under a previous Gradalis protocol are considered for this study.

Participants will be managed in an outpatient setting. Hematologic function, liver enzymes, renal function and electrolytes will be monitored. Blood for immune function analyses in response to autologous tumor antigens will be collected at screening, Day 1 (prior to Vigil administration) at Cycles 2, 4, and 6, end of treatment (EOT); 3 months after EOT, and every 6 months thereafter for those in response follow up. For subjects with Ewing's sarcoma, blood for ctDNA analysis will be collected at screening, on Day 1 prior to Vigil administration at Cycles 2, 3, 4, and 6, and EOT.

Study Type Expanded Access
Expanded Access Type Intermediate-size Population
Intervention Biological: Vigil
Vigil is composed of autologous tumor cells harvested from the patient at the time of initial de-bulking surgery which are then transfected extracorporeally, with a plasmid encoding for the gene for GM-CSF, an immune-stimulatory cytokine, and a bifunctional, short hairpin RNA which specifically knocks down the expression of furin, the critical convertase responsible for production of the two TGβ isoforms (TGFβ-1 and TGFβ-2).
Other Names:
  • Engineered Autologous Tumor Cell Immunotherapy
  • FANG
  • IND 14205
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Available
Contact: Gladice Wallraven 214-442-8124
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT03842865
Responsible Party Gradalis, Inc.
Study Sponsor Gradalis, Inc.
Collaborators Not Provided
Study Director: Luisa Manning, MD Gradalis, Inc.
PRS Account Gradalis, Inc.
Verification Date March 2019