Early Phase 1 Study of Autologous T Cells Targeting GD2 Antigen with IL-15 and Safety Switch for Treatment of Advanced Lung Cancer

What this Trial Is About

Researchers are evaluating the safety of an experimental treatment called iC9-GD2.CAR.IL-15 T cells in adults with extensive stage lung cancer or stage IV non-small cell lung cancer that is platinum-refractory and who have received PD-1 andor PD-L1 therapy. This phase 1, single-center, open-label study focuses on determining the safe dose and maximum tolerated dose of this new treatment. The therapy combines modified T cells and antibodies to target cancer cells more effectively than either alone. The treatment involves two main steps. First, blood is collected from each subject to isolate and modify their T cells to create iC9-GD2.CAR.IL-15 T cells. Next, these modified cells are given back to the subject through an intravenous infusion over 5 to 10 minutes. This therapy includes a safety switch called inducible caspase 9 iC9 and targets the GD2 antigen on cancer cells, with the goal of improving immune response against lung cancer. Participants will be monitored closely for up to four weeks to assess any side effects such as adverse events, cytokine release syndrome, and neurotoxicity. Researchers will also evaluate the recommended dose for future studies, overall response rate, progression-free survival, overall survival, and duration of response over a two-year period. Additional assessments include GD2 expression on tumor cells and its correlation with treatment response. The entire study duration and follow-up extend up to two years from treatment administration.

Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer