Expanded Access of Vigil in Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03842865|
Expanded Access Status : Temporarily not available
First Posted : February 15, 2019
Last Update Posted : February 8, 2021
|Condition or disease||Intervention/treatment|
|Solid Tumor Ewing Sarcoma Ewing's Tumor Metastatic Ewing's Sarcoma Metastatic Advanced Gynecological Cancers Ovarian Cancer Cervical Cancer Uterine Cancer||Biological: Vigil|
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|
|Official Title:||An Expanded Access Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Advanced Solid Tumors|
- 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
- IND 14205
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842865
|United States, Texas|
|Texas Oncology - Pediatrics|
|Dallas, Texas, United States, 75230|
|Study Director:||Luisa Manning, MD||Gradalis, Inc.|