Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors
Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors: A Phase I Trial (FAST TILS 2)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 79 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 days, 5 years, 6 days
- Procedures mentioned: Infusions, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of Fast TIL and how well it fights cancer using a person's own immune cells. It is for adults with cancer in the lining around the lungs and fluid buildup, after standard treatments have failed or run out. The cells are grown in a lab and given through a tube into the space around the lungs, along with a drug called IL-2.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 to 79.
- Have cancer in the lining around the lungs, confirmed by a tissue test, with fluid buildup and symptoms. Standard treatments must have failed or run out.
- If able to become pregnant, have a negative pregnancy test and use approved birth control if sexually active for at least 12 months after cell treatment. Men must use birth control from enrollment through 4 months after the preparation treatment.
- Have a heart test showing that the heart pumps out at least 45% of its blood with each beat.
- Not need extra oxygen or have shortness of breath right after fluid is drained.
- Be fully active or able to do light work despite limits on hard physical activity.
- Be expected to live more than 12 weeks.
- Understand the study's risks and steps, give consent on your own, and agree to collection of personal background and health data.
Who can't join
- Have HIV, hepatitis B, or hepatitis C with the virus actively multiplying, or be receiving treatment for a bacterial, fungal, or viral infection. People with HIV controlled by medicine may be considered.
- Have had a heart attack within 6 months, have symptoms from heart artery or valve disease, or have an uncontrolled uneven heartbeat.
- Have used an experimental drug within 30 days before fluid collection, or cancer-killing chemotherapy or radiation within 2 weeks. The 2-week rule does not apply to immune checkpoint antibody treatments.
- Have taken more than 10 mg of prednisone daily, or an equal dose of another steroid, within 2 weeks before fluid collection. Also excluded: immune-suppressing medicine that cannot be stopped for 4 weeks before collection.
- Have blood tests showing serious blood, liver, bile system, or kidney problems, including low blood cell counts or needing transfusions to keep counts high enough.
- Be pregnant or breastfeeding, or have had a solid organ transplant.
- Be judged unlikely to follow study visits or steps, or unable to give informed consent. The study also excludes vulnerable groups, such as people who are homeless, have developmental disabilities, or are prisoners.
- Have a documented history of anaphylaxis, a severe allergic reaction, from penicillin.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. 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. 2. Patients will be ≥ 18 and \< 80 years of age. 3. 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. 4. Cardiac ejection fraction ≥ 0.45 by MUGA or echocardiography. 5. No requirement for supplemental oxygen and no dyspnea immediately after effusion drainage. 6. ECOG Performance Status 0 or 1. 7. Patients must have an expected survival \> 12 weeks. 8. Patients must be able to comprehend the risks and methods used in this clinical trial and independently consent to participate. 9. Patients must consent to collection of demographic and clinical data. Exclusion Criteria: 1. Infection with HIV and active viral replication. Patients with an undetectable viral load on Anti-retroviral Therapy (ART) can be considered for participation on this protocol. 2. Infection with hepatitis B and active viral replication. 3. Infection with hepatitis C and active viral replication. 4. Patients currently being treated for bacterial, fungal or viral infection. 5. Documented myocardial infarction within 6 months of study participation and/or symptomatic coronary artery or valvular disease or uncontrolled arrhythmia. 6. Investigational drug use within 30 days before effusion collection. 7. 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. 8. Corticosteroid therapy \> 10 mg of prednisone (biological equivalent) daily within 2 weeks before effusion collection. 9. Immunosuppressive therapy that cannot be stopped for 4 weeks prior to effusion collection as deemed by the prescribing physician. 10. 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. 11. Pregnant or lactating females. 12. Prior solid organ transplantation 13. Patients who, in the opinion of the Investigator, will be non-compliant with study schedules or procedures. 14. 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. 15. Patients with documented anaphylaxis as a result of penicillin allergy.
Study sites (1)
PA
- AHN West Penn Hospital · Pittsburgh, PA 15224Patrick Wagner, MD · Study contact · 412-359-3731 · patrick.wagner@ahn.orgAHN Clinical Trial Contact · Study contact · 412-359-3731 · clinicaltrials@ahn.orgDavid Bartlett, MD · Sub-investigatorJohn Lister, MD · Sub-investigatorMore trials in Pittsburgh