Phase 1 Study of Fast TIL Immunotherapy Using Patients Own Pleural T Cells to Treat Cancer That Has Spread to the Pleura

What this Trial Is About

Researchers are evaluating a new immunotherapy called Fast TIL, an Adoptive Cellular Therapeutic ACT, for patients with cancer that has spread to the pleura or pleural mesothelioma. This first-in-human Phase 1 trial studies the safety and effectiveness of this treatment, which is delivered locally to the pleura. The study also includes ancillary research using pleural fluid samples to understand why the treatment may work or not. The treatment involves collecting pleural fluid from participants to isolate and expand their pleural infiltrating T-cells PIT in the lab, creating the ACT product. Participants receive a single dose of this ACT product through a pleural catheter. Along with the ACT product, low-dose Interleukin-2 IL-2 is given intrapleurally to stimulate the expanded cells. Before treatment, participants undergo outpatient lymphodepleting chemotherapy. The active treatment phase lasts about three weeks, with IL-2 administered for two days after ACT infusion. During the study, participants may stay in the hospital for up to six days and will have follow-up visits over five years. Blood samples and pleural fluid are collected to monitor treatment response and changes in the pleural environment. The research team will assess the feasibility of producing the ACT product, safety of the treatment, and tumor response rates. This study carries unknown risks, including serious side effects, as it is the first time this therapy is being tested in humans.

Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease