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®.

Clinical Trials
Details
Gradalis Immunotherapy Platform
Ewing's Sarcoma
Phase II
Ewing's Sarcoma
Not Recruiting

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

Stage III/IV Ovarian Cancer
Phase III
Stage III/IV Ovarian Cancer
Not Recruiting

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)

Advanced Women’s Cancer
Phase II
Advanced Women’s Cancer
Recruiting

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

Advanced Gynecological Cancer
Phase II
Advanced Gynecological Cancer
Recruiting

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)

Gradalis® Clinical Trials