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

This research study aims to evaluate the safety and effectiveness of a novel immunotherapy, Fast TIL, an Adoptive Cellular Therapeutic (ACT), to fight cancer that has spread to the pleura or pleural mesothelioma. The ACT product is created at AHN West Penn using the participant's pleural infiltrating T-cells (PIT). It is administered through a pleural catheter along with the drug Interleukin-2 (IL-2). Based on previous research it is believed that it may help fight the tumor and relieve symptoms. As a participant, their pleural fluid will be collected and the PIT cells will be isolated and expanded in the lab to create the ACT product. Before receiving the ACT product through their pleural catheter, they will undergo outpatient lymphodepleting chemotherapy. LDC is a standard procedure for many approved immunotherapy treatments Following the infusion, they'll receive IL-2 through the catheter for two days to stimulate the expanded PIT cells. The active treatment phase lasts about three weeks, with follow-up visits over five years at AHN West Penn Hospital, potentially requiring a hospital stay of up to six days. Blood samples will be taken to monitor their response. As this is a first-in-human study, treatment carries an unknown risk up to and including death from toxicity. However, the risks of similar immunotherapy treatments are well documented.

NCT Number	NCT07443020
Lead Sponsor	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) Collaborators: AHN Cancer Institute (AHNCI)
Conditions	Malignant Pleural Effusion, Malignant Mesothelioma, Pleural Effusion, Malignant, Metastasis to Pleura
Enrollment	10 participants
Start Date	2026-05
Primary Completion	2033-03 (estimated)
Study Completion	2038-03 (estimated)
Updated on ClinicalTrials.gov	2026-04-07