Fast TILs for Metastatic Pleural Effusions or Mesothelioma
This study is testing a new immunotherapy called Fast TIL, an adoptive cellular therapy (ACT), to treat cancer that has spread to the lining of the lungs (pleura) or malignant mesothelioma. The ACT product is made from your own immune cells (T-cells) taken from your pleural fluid. These cells are grown in a lab and then given back to you through a catheter in your chest, along with a drug called Interleukin-2 (IL-2). The goal is to see if this treatment is safe and effective in fighting the cancer and relieving symptoms. You would need to have symptomatic, biopsy-proven malignant disease to the pleura or mesothelioma, and have already tried standard treatments that didn't work. The study plans to enroll 10 participants between 18 and 79 years old.
- Study design
- This is a first-in-human study, meaning it's the first time this specific treatment is being tested in people. It is an interventional study, and the planned enrollment is 10 participants.
- What's involved
- Your pleural fluid will be collected to create the ACT product. Before receiving the ACT product, you will have outpatient chemotherapy. The ACT product and IL-2 will be given through a pleural catheter.
- Compensation
- Not stated in the trial record.
- Follow-up
- The feasibility of manufacturing the ACT product will be measured at 30 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Patrick Wagner, MD · PRINCIPAL_INVESTIGATOR · Allegheny Health Network
Who to contact
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What this trial measures
- Document the feasibility of local manufacture of ACT product from drained pleural effusions using the CliniMACS Prodigy® device30 days
flow cytometry for cellular ACT identity
- Document the feasibility of local manufacture of ACT product from drained pleural effusions using the CliniMACS Prodigy® device30 days
cytotoxicity assays for ACT potency
- Document the feasibility of local manufacture of ACT product from drained pleural effusions using the CliniMACS Prodigy® device30 days
flow cytometry for cellular ACT purity
- To demonstrate the safety of intrapleural administration of the locally manufactured ACT product plus Interleukin 2 (IL-2) to study patients5 years
incidence of Treatment-Emergent Adverse Events (Safety) of intrapleural administration of the locally manufactured ACT product, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.