Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors (NCT07443020) | Clinical Trial Compass
RecruitingPhase 1
Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors
United States10 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with symptomatic, biopsy-proven malignant to the pleura, or mesothelioma with pleural effusions. Patients must have received and be refractory to available standard of care (SOC) therapy specific to their cancer type and must have exhausted or failed available standard of care with clinical benefit.
. Patients will be ≥ 18 and \< 80 years of age.
. Female patients of childbearing potential must have a negative urine or serum pregnancy test and if sexually active must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), an injectable contraceptive (such as Depo-Provera), or an oral contraceptive. Active contraception should continue for at least 12 months after ACT administration.
. Cardiac ejection fraction ≥ 0.45 by MUGA or echocardiography.
. No requirement for supplemental oxygen and no dyspnea immediately after effusion drainage.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Document the feasibility of local manufacture of ACT product from drained pleural effusions using the CliniMACS Prodigy® device
Timeframe: 30 days
2
Document the feasibility of local manufacture of ACT product from drained pleural effusions using the CliniMACS Prodigy® device
Timeframe: 30 days
3
Document the feasibility of local manufacture of ACT product from drained pleural effusions using the CliniMACS Prodigy® device
Timeframe: 30 days
4
To demonstrate the safety of intrapleural administration of the locally manufactured ACT product plus Interleukin 2 (IL-2) to study patients
Timeframe: 5 years
Trial details
NCT IDNCT07443020
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
. Patients must have an expected survival \> 12 weeks.
. Patients must be able to comprehend the risks and methods used in this clinical trial and independently consent to participate.
Exclusion criteria
. Infection with HIV and active viral replication. Patients with an undetectable viral load on Anti-retroviral Therapy (ART) can be considered for participation on this protocol.
. Infection with hepatitis B and active viral replication.
. Infection with hepatitis C and active viral replication.
. Patients currently being treated for bacterial, fungal or viral infection.
. Documented myocardial infarction within 6 months of study participation and/or symptomatic coronary artery or valvular disease or uncontrolled arrhythmia.
. Investigational drug use within 30 days before effusion collection.
. Cytotoxic anti-cancer or radiation therapy administration within 2 weeks of effusion collection. The exclusion does not apply to patients receiving monoclonal antibody therapy targeting immune checkpoint molecules.
. Corticosteroid therapy \> 10 mg of prednisone (biological equivalent) daily within 2 weeks before effusion collection.