Actively Recruiting
Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease: A Phase I Trial
Led by David Bartlett, MD · Updated on 2026-01-15
10
Participants Needed
1
Research Sites
260 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
Researchers are evaluating the safety and effectiveness of a new immunotherapy called Fast TIL, an Adoptive Cellular Therapeutic (ACT), for treating cancer that has spread to the pleura or pleural mesothelioma. This first-in-human Phase 1 trial uses the participant's own pleural infiltrating T-cells (PIT) to create the ACT product, aiming to help fight tumors and relieve symptoms. The study also includes ancillary research to understand why the treatment may succeed or fail by analyzing pleural fluid collected before and after treatment. The treatment involves a single dose of the ACT product delivered directly into the pleura through an indwelling pleural catheter, combined with low-dose Interleukin-2 (IL-2) administered intrapleurally to stimulate the infused cells. Before the infusion, participants receive outpatient lymphodepleting chemotherapy. IL-2 is given starting about 2 hours after ACT infusion and repeated every 8 to 16 hours for up to four doses. The active treatment phase lasts approximately three weeks, with follow-up visits extending up to five years. Participants will have their pleural fluid collected to isolate and expand their T-cells in the lab for therapy preparation. They may require a hospital stay of up to six days during treatment. Blood samples and clinical assessments will monitor response and safety over the follow-up period. The trial aims to document the manufacturing feasibility of the ACT product, safety of administration, changes in pleural fluid, and treatment response rates. As this is a first-in-human study, risks include unknown toxicities, including the possibility of death.
CONDITIONS
Brief 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-proven malignant pleural disease or mesothelioma with pleural effusions
- Patients aged 18 to less than 80 years
- Female patients of childbearing potential must have a negative pregnancy test and use effective contraception during and for 6 months after treatment
- Male patients must agree to use birth control during and for 6 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 effusion drainage
- Karnofsky performance score of 70 or higher
- Expected survival longer than 12 weeks
- Ability to understand and consent to the study
- Consent 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; those 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
- Recent myocardial infarction within 6 months or symptomatic heart disease
- Use of investigational drugs within 30 days before effusion collection
- Cytotoxic anti-cancer or radiation therapy within 2 weeks before effusion collection (except immune checkpoint monoclonal antibodies)
- Use of corticosteroids over 10 mg prednisone daily within 2 weeks before effusion collection
- Immunosuppressive therapy that cannot be stopped 4 weeks prior to effusion collection
- Significant blood, liver, or kidney abnormalities as defined by lab tests
- Pregnant or breastfeeding females
- Prior solid organ transplantation
- Non-compliance risk or inability to consent
- Vulnerable populations such as homeless, developmentally disabled, prisoners, or those unable to comply
- History of anaphylaxis to 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.
1 visit (in-person)
Duration - Up to 2 days
Participants receive a single dose of adoptive cellular therapy product delivered intrapleurally via a pleural catheter. Low dose Interleukin-2 (IL-2) is administered intrapleurally starting about 2 hours after the ACT infusion and given every 8 to 16 hours thereafter, for up to 4 doses as tolerated.
1 treatment visit with multiple IL-2 administrations over 1 to 2 days
Duration - Up to 5 years
Participants are monitored for safety and response to treatment, including assessments of pleural fluid and cellular changes, and overall treatment response.
Regular follow-up visits during the first 60 days and longer-term visits up to 5 years
Trial Site Locations
Total: 1 location
1
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
D
David Bartlett, 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
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