Gradalis® Clinical Trials

Generations Group

Vigil® is a fully personalized cancer immunotherapy utilizing genetically modified patient’s own tumor cells.

To date we have conducted a Phase 1 study identifying the clinical dose and establishing the early safety profile for the platform. The tumor types studied in Phase 1 included, but not limited to: Ovarian cancer, breast cancer, melanoma, Ewing’s sarcoma, non-small cell lung cancer, colon cancer, and hepatocellular cancer. We have also initiated Phase 2 studies in advanced ovarian cancer and Ewing’s sarcoma.

We are currently conducting clinical studies with primary focus on Vigil® immunotherapy in patients with recurrent / refractory Ewing’s Sarcoma, as well as in combination with other immunotherapies, such as checkpoint inhibitors in patients with advanced women’s cancers.

Below are ongoing clinical trials involving Vigil®:

 
  • Ewing’s Sarcoma: A two-part Phase IIb Trial of Vigil (bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing’s Sarcoma

Clinical Trials Study Details

Status: Active, Not Recruiting

  • Stage III/IV Ovarian Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects with Stage IIIb-IV Ovarian Cancer in Clinical Complete Response following Surgery and Primary Chemotherapy (VITAL)

Clinical Trials Study Details

Status: Active, Not Recruiting

  • Advanced Women’s Cancer: Pilot Study of Durvalumab (MEDI4736) in Combination with Vigil in Advanced Women’s Cancers

Clinical Trials Study Details

Status: Active, Not Recruiting

  • Advanced Gynecological Cancer: A Randomized, Intra-patient Crossover, Safety, Biomarker and Anti-Tumor Activity Assessment of the Combination of Atezolizumab and Vigil in Patients with Advanced Gynecological Cancers (A Companion Study to CL-PTL-119 VITAL)

Clinical Trials Study Details

Status: Active

  • Pbi-shRNA™ EWS/FLI1 Type 1 LPX in Subjects With Advanced Ewing's Sarcoma:Phase I Trial of Pbi-shRNA™ EWS/FLI1 Type 1 Lipoplex (LPX) in Subjects With Advanced Ewing's Sarcoma

    Clinical Trials Study Details

    Status: Active, Not Recruiting