Actively Recruiting
Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors: A Phase I Trial
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
260 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
Researchers are evaluating a new immunotherapy called Fast TIL, an Adoptive Cellular Therapeutic (ACT), to treat cancer that has spread to the pleura or pleural mesothelioma. This Phase 1 trial aims to assess the safety and effectiveness of this treatment, which uses the participant's own pleural infiltrating T-cells (PIT) expanded in the lab. The study also includes ancillary research to understand why the treatment works or fails. Participants receive a single dose of the ACT product through a pleural catheter, combined with low-dose Interleukin-2 (IL-2) administered intrapleurally to stimulate the therapy. Before the infusion, participants undergo outpatient lymphodepleting chemotherapy. IL-2 is given starting about two hours after the ACT infusion and repeated every 8 to 16 hours for up to four doses. The active treatment phase lasts about three weeks. Throughout the study, participants will have pleural fluid and blood samples collected to monitor their response. Follow-up visits will continue for up to five years, with possible hospital stays of up to six days during treatment. The primary outcomes include documenting the feasibility of manufacturing the ACT product locally and demonstrating the safety of the treatment. Secondary outcomes assess changes in pleural fluid and cellular composition, as well as overall and complete response rates to therapy.
CONDITIONS
Brief 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 cancer spread to the pleura or mesothelioma with pleural effusions.
- Patients must have received and not responded to all available standard therapies for their cancer.
- Age 18 to less than 80 years.
- Female participants of childbearing potential must have a negative pregnancy test and use effective contraception during and for 12 months after treatment.
- Male participants must use birth control from enrollment through 4 months after treatment.
- Cardiac ejection fraction of 0.45 or higher by MUGA or echocardiography.
- No need for supplemental oxygen and no shortness of breath immediately after pleural fluid drainage.
- ECOG Performance Status of 0 or 1.
- Expected survival greater than 12 weeks.
- Ability to understand the risks and independently consent to participate.
- Consent to collection of demographic and clinical data.
You will not qualify if you...
- Active HIV infection with viral replication. Undetectable viral load on therapy allowed.
- Active hepatitis B or C infection with viral replication.
- Current bacterial, fungal, or viral infection.
- Myocardial infarction within 6 months or symptomatic heart disease or uncontrolled arrhythmia.
- Use of investigational drugs within 30 days before fluid collection.
- Cytotoxic anti-cancer or radiation therapy within 2 weeks before fluid collection, except certain monoclonal antibody therapies.
- Corticosteroid use 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.
- Pregnant or breastfeeding females.
- Prior solid organ transplant.
- Non-compliance risk or inability to follow study procedures.
- Vulnerable populations unable to give informed consent.
- History of anaphylaxis from penicillin allergy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 4 days
Participants receive a single intrapleural dose of adoptive cellular therapy (ACT) product derived from their own pleural infiltrating T-cells, followed by low dose intrapleural Interleukin-2 (IL-2) administered every 8 to 16 hours for up to 4 doses as tolerated.
1 treatment visit with up to 4 additional IL-2 dosing sessions
Duration - Up to 5 years
Participants are monitored for safety and treatment response over time after the intervention.
Periodic visits during the follow-up period
Trial Site Locations
Total: 1 location
1
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
P
Patrick Wagner, MD
A
AHN Clinical Trial Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here