Phase 1 Study of Fast TILs Immunotherapy Delivered Through Pleural Catheter to Treat Cancer Spread to the Pleura or Mesothelioma

What this Trial Is About

Researchers are evaluating a new immunotherapy called Fast TIL, an Adoptive Cellular Therapeutic ACT, to treat cancer that has spread to the pleura or pleural mesothelioma. This Phase 1 trial aims to assess the safety and effectiveness of this treatment, which uses the participants own pleural infiltrating T-cells PIT expanded in the lab. The study also includes ancillary research to understand why the treatment works or fails. Participants receive a single dose of the ACT product through a pleural catheter, combined with low-dose Interleukin-2 IL-2 administered intrapleurally to stimulate the therapy. Before the infusion, participants undergo outpatient lymphodepleting chemotherapy. IL-2 is given starting about two hours after the ACT infusion and repeated every 8 to 16 hours for up to four doses. The active treatment phase lasts about three weeks. Throughout the study, participants will have pleural fluid and blood samples collected to monitor their response. Follow-up visits will continue for up to five years, with possible hospital stays of up to six days during treatment. The primary outcomes include documenting the feasibility of manufacturing the ACT product locally and demonstrating the safety of the treatment. Secondary outcomes assess changes in pleural fluid and cellular composition, as well as overall and complete response rates to therapy.

Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors