Actively Recruiting
Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease
Led by David Bartlett, MD · Updated on 2026-01-15
10
Participants Needed
1
Research Sites
613 weeks
Total Duration
On this page
Sponsors
D
David Bartlett, MD
Lead Sponsor
M
Miltenyi Biotec, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with symptomatic, biopsy-confirmed cancer spread to the pleura or pleural mesothelioma with pleural effusions
- Patients must have failed or not benefited from standard treatments for their cancer
- Age 18 to under 80 years
- Female patients of childbearing potential must have a negative pregnancy test and use effective contraception; male patients must agree to birth control during the study and for 6 months after
- Cardiac ejection fraction of 0.45 or higher by MUGA or echocardiography
- No need for supplemental oxygen and no shortness of breath immediately after fluid drainage
- Karnofsky performance score of 70 or higher
- Expected survival longer than 12 weeks
- Ability to understand and consent independently to participate
- Agreement to collection of demographic and clinical data
You will not qualify if you...
- Patients with breast, kidney, lung, pancreatic, prostate, ovarian, rare cancers, or melanoma
- Active HIV infection with viral replication; patients with undetectable viral load on ART may be eligible
- Active hepatitis B or C infection with viral replication
- Current treatment for bacterial, fungal, or viral infections
- Heart attack within 6 months or symptomatic heart disease or uncontrolled arrhythmia
- Use of investigational drugs within 30 days before fluid collection
- Chemotherapy or radiation within 2 weeks before fluid collection, except monoclonal antibody therapy targeting immune checkpoints
- Use of corticosteroids over 10 mg prednisone daily within 2 weeks before fluid collection
- Immunosuppressive therapy that cannot be stopped 4 weeks before fluid collection
- Significant blood, liver, or kidney abnormalities based on lab tests
- Pregnant or breastfeeding women
- Previous solid organ transplant
- Likely non-compliance with study procedures
- Belonging to vulnerable populations unable to consent or comply
- History of severe allergic reaction to penicillin
AI-Screening
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Trial Site Locations
Total: 1 location
1
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
D
David Bartlett, MD
CONTACT
A
AHN Clinical Trial Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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