clinical trial · NCT07192900

Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease

David Bartlett, MD·phase1·recruiting·n = 10

Malignant Pleural EffusionMalignant MesotheliomaPleural Effusion, MalignantMetastasis to Pleuralocally manufactured adoptive cellular therapy (ACT) productInterleukin-2

brief summary

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.

started

Mar 1, 2026

primary completion

Dec 1, 2032

completion

Dec 1, 2037

last updated

Jan 15, 2026

detailed description

This is a first-in-human Phase 1 trial of short-term expanded pleural T cells to treat cancer metastatic to the pleura. Expanded cells will be delivered intrapleurally in combination with intrapleural IL-2, administered at a dose that ensures high local concentration while minimizing systemic exposure.

Ancillary studies conducted in conjunction with the trial will leverage drained pleural effusions collected before and after intervention to determine why the intervention is succeeding or failing.

official title

Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease: A Phase I Trial

full record on clinicaltrials.gov ↗

sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol