Tests a cell therapy for cancer that has spread to the pleura
Tests Fast TIL cell therapy with IL-2 in adults with pleural cancer.
Key facts
- Who runs it
- David Bartlett, MD
- Where
- Pittsburgh, United StatesSee the site
- Trial code
- Registry title
- Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 10 people, planned
- Started
- 3 Jun 2026
- Expected to end
- Apr 2038
- Type of study
- Interventional
- Treatments tested
- locally manufactured adoptive cellular therapy (ACT) product
- Interleukin-2
- Record updated
- 4 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cancer that has spread to the pleura, or pleural mesothelioma, with fluid around the lung and symptoms, whose standard treatment has stopped working.
- Age
- 18 to 79 years (at least 18 and under 80)
- Sex
- All sexes
- Disease stage
- Symptomatic cancer proven by biopsy in the pleura, or mesothelioma, with pleural effusion. No oxygen needed and no breathlessness right after the fluid is drained. ECOG 0 or 1. Expected survival over 12 weeks.
- Earlier treatment
- Must have had standard treatment for their cancer type and not responded to it or run out of options. Cytotoxic cancer treatment or radiation within 2 weeks before fluid collection, and any investigational drug within 30 days before, are not allowed.
- Biomarker or test result
- Heart ejection fraction of 0.45 or more. Certain blood test limits for liver, kidney, haemoglobin, white cells and platelets are required.
Main reasons for not taking part
- Breast, kidney, lung, pancreatic, prostate, ovarian, rare cancers and melanoma
- Pregnant or breastfeeding
- Prior solid organ transplant
- Active HIV, hepatitis B or hepatitis C infection, or a current infection being treated
- Heart attack within 6 months, symptomatic heart disease or uncontrolled arrhythmia
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- 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. Male participants must be willing to practice birth control from the time of enrollment on this study and for 4 months after receiving the preparative regimen
- Cardiac ejection fraction ≥ 0.45 by Multiple-Gated Acquisition (MUGA) or echocardiography
- No requirement for supplemental oxygen and no dyspnea immediately after effusion drainage
- ECOG Performance Status 0 or 1
- 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
- Patients must consent to collection of demographic and clinical data
Who cannot take part
- 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 milligrams (mg) of prednisone (biological equivalent) daily within 2 weeks before effusion collection
- Immunosuppressive therapy that cannot be stopped for 4 weeks prior to effusion collection as deemed by the prescribing physician
- Prior solid organ transplantation
- Patients with breast, kidney, lung, pancreatic, prostate, ovarian, rare cancers, and melanoma
- Infection with Human Immunodeficiency Virus (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
- Patients who belong to a vulnerable population such as the homeless, the developmentally disabled and prisoners or have any condition that impairs their ability to provide informed consent or comply with study schedules or procedures
- Patients with documented anaphylaxis as a result of penicillin allergy
- Laboratory abnormalities that indicate clinically significant hematological, hepatobiliary, or renal disease:; AST/SGOT > 2.0 times the upper limit of normal ALT/SGPT > 2.0 times the upper limit of normal Total bilirubin > 2.0 times the upper limit of normal, unless patient has Gilbert Syndrome (>3.0 times the upper limit of normal) Hemoglobin < 8 gm/dL or dependent upon transfusion to maintain ≥ 8 gm/dL White blood cell count < 2,000/mm3 Platelet count < 100,000/mm3 or dependent upon transfusion to maintain ≥ 100,000 mm3 Creatinine > 2.0 times the upper limit of normal or calculated creatinine clearance ≤ 40 mL/min
- Pregnant or lactating females
- Patients who, in the opinion of the Investigator, will be non-compliant with study schedules or procedures
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 79 years old?
Where in United States
- AHN West Penn HospitalPittsburgh, United StatesContact: Patrick Wagner, MD (sub-investigator)Taking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- locally manufactured adoptive cellular therapeutic (ACT) productTreatment being tested
Single dose, intrapleural delivery (via indwelling pleural catheter) of adoptive cellular therapy (ACT) product derived from autologous pleural infiltrating T-cells. Low dose Interleukin-2 (IL-2) will also be administered intrapleural at the dose of 20 milliliters (mL) at 1 x 10⁵ International Units (IU)/mL starting approximately 2 hours after ACT infusion and every 8 to 16 hours thereafter, as tolerated, for up to 4 doses (total 8 x 10⁶ IU).
Treatment: locally manufactured adoptive cellular therapy (ACT) product and Interleukin-2
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease: A Phase I Trial
- Plain-language title
- Tests a cell therapy for cancer that has spread to the pleuraGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07192900, who can take part
- Record updated
- 4 August 2026