RecruitingPhase 1NCT07192900

Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease

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


Sponsor

David Bartlett, MD

Enrollment

10 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a personalized immune cell therapy called "Fast TILs" — immune cells taken from a patient's own fluid around the lungs — for people with cancer that has spread to the lining of the chest (pleura) or mesothelioma with pleural effusions, and who have not responded to standard treatments. **You may be eligible if...** - You are between 18 and 79 years old - You have biopsy-confirmed cancer involving the pleura, or mesothelioma with pleural effusions - Your cancer has progressed despite available standard treatments - Female participants must have a negative pregnancy test and use effective contraception for at least 6 months after treatment; male participants must also use contraception **You may NOT be eligible if...** - You have not yet tried standard treatments for your cancer type - You are under 18 or 80 years old or older - You have conditions that make immune cell therapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALlocally manufactured adoptive cellular therapy (ACT) product

Single dose, intrapleural delivery (via indwelling pleural catheter) of adoptive cellular therapy (ACT) product derived from autologous pleural infiltrating T-cells.

DRUGInterleukin-2

Low dose Interleukin-2 (IL-2) will also be administered intrapleural at the dose of 20 milliliters (mL) at 1 x 10⁵ International Units (IU)/mL starting approximately 2 hours after ACT infusion and every 8 to 16 hours thereafter, as tolerated, for up to 4 doses (total 8 x 10⁶ IU).


Locations(1)

AHN West Penn Hospital

Pittsburgh, Pennsylvania, United States

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NCT07192900


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