Expanded Access of Vigil in Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03842865|
Expanded Access Status : Available
First Posted : February 15, 2019
Last Update Posted : March 20, 2019
|First Submitted Date||February 13, 2019|
|First Posted Date||February 15, 2019|
|Last Update Posted Date||March 20, 2019|
|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.|
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|
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).
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||Available|
|Listed Location Countries||United States|
|Removed Location Countries|
|Responsible Party||Gradalis, Inc.|
|Study Sponsor||Gradalis, Inc.|
|PRS Account||Gradalis, Inc.|
|Verification Date||March 2019|