A Phase I Study of Autologous CAR-T Cells Targeting the B7-H3 Antigen and Containing the Inducible Caspase 9 Safety Switch in Subjects With Refractory Pancreatic Ductal Adenocarcinoma (PDAC)

What this Trial Is About

Researchers are studying a new gene therapy called autologous T lymphocyte chimeric antigen receptor cells targeting the B7-H3 antigen (iC9.CAR.B7-H3 T cells) in adults with pancreatic ductal adenocarcinoma that has returned after standard treatment. This phase 1 trial aims to evaluate the safety and tolerability of this experimental treatment, which includes a safety switch called inducible caspase 9. The study focuses on patients whose cancer has been resistant or relapsed despite previous therapies. Participants receive the investigational iC9-CAR.B7-H3 T cells, which are made from their own blood cells and modified to target cancer cells. These modified CAR-T cells are given as an intravenous infusion over 5 to 10 minutes. The study uses a dose-escalation design to find a safe and effective dose by starting with a low amount of cells and gradually increasing it. The trial will determine the recommended dose for future research based on safety and manufacturing feasibility. During the study, participants are closely monitored for adverse events including cytokine release syndrome and neurotoxicity for up to four weeks after infusion. Researchers will also assess longer-term outcomes such as disease progression, survival, and response rates for up to two years. Additional tests will measure the presence of the B7-H3 antigen and how many subjects successfully receive the CAR-T cell infusion. Overall, the study involves regular follow-up visits and evaluations to track safety and effectiveness over time.

Autologous CAR-T Cells Targeting B7-H3 in PDAC