NCT05936216

TVI-Brain-1 in Expanded Access Patient

Expanded Access Use Of Tvi-Brain-1 For Treatment Of Recurrent Grade 4 Astrocytoma (Glioblastoma Multiforme; GBM)

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: TVAX Biomedical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

TVI-Brain-1 is being offered as a potential treatment option to a Named Patient (Emergency Use Authorization IND) for recurrent glioblastoma as there is no effective systemic treatment available for this disease or patient. TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to generate large numbers of those 'killer' white blood cells and to deliver those cells into your body so that they can kill your cancer cells.

Detailed description

The TVI-Brain-1 treatment involves several steps. First, the patient's cancer will be surgically removed to provide cells for the vaccine. Second, the patient will be vaccinated with the vaccine formulation. Third, the patient's blood will be filtered for killer T cell precursors which will then be cultured and stimulated to reach a higher (killer) activity level. Fourth, the activated cells will be infused into the patient's bloodstream so that they will be able to attack the cancer.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
BIOLOGICAL	TVI-Brain 1	Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.

Timeline

• First posted: 2023-07-07
• Last updated: 2024-10-01

Locations

1 site across 1 country: United States