Actively Recruiting
Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors
Led by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Updated on 2026-04-07
10
Participants Needed
1
Research Sites
617 weeks
Total Duration
On this page
Sponsors
A
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Lead Sponsor
A
AHN Cancer Institute (AHNCI)
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 Pleural Effusions From Epithelial or Mesothelial Primary Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with symptomatic, biopsy-proven malignant pleural disease or mesothelioma with pleural effusions who have failed or are refractory to available standard of care therapies.
- Age 18 to less than 80 years.
- Female patients of childbearing potential must have a negative pregnancy test and use acceptable contraception during and for 12 months after treatment.
- Male patients must agree to use birth control from enrollment through 4 months after treatment.
- Cardiac ejection fraction of 0.45 or higher as measured by MUGA or echocardiography.
- No need for supplemental oxygen and no shortness of breath immediately after effusion drainage.
- ECOG Performance Status of 0 or 1.
- Expected survival longer than 12 weeks.
- Ability to understand study risks and provide informed consent.
- Consent to collection of demographic and clinical data.
You will not qualify if you...
- Active HIV infection with viral replication (undetectable viral load on ART allowed).
- Active hepatitis B or C infection with viral replication.
- Current treatment for bacterial, fungal, or viral infection.
- Myocardial infarction within 6 months, symptomatic coronary artery or valvular disease, or uncontrolled arrhythmia.
- Use of investigational drugs within 30 days before effusion collection.
- Cytotoxic chemotherapy or radiation within 2 weeks of effusion collection (monoclonal antibody therapy targeting immune checkpoints allowed).
- Corticosteroid therapy over 10 mg prednisone daily within 2 weeks before effusion collection.
- Immunosuppressive therapy that cannot be stopped for 4 weeks prior to effusion collection.
- Significant laboratory abnormalities indicating hematological, liver, or kidney disease.
- Pregnant or breastfeeding females.
- Prior solid organ transplant.
- Non-compliance or inability to follow study schedules or procedures.
- Vulnerable populations such as homeless, developmentally disabled, prisoners, or those unable to give informed consent.
- Documented anaphylaxis to penicillin allergy.
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
P
Patrick Wagner, 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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