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New treatment option for Malignant Pleural Effusion
Official title Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors
ClinicalTrials.gov ID: NCT07443020
What this study is testing
What is locally manufactured adoptive cellular therapy (ACT) product?
locally manufactured adoptive cellular therapy (ACT) product is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignant pleural effusion.
Also referred to as ACT, Fast TIL.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- Patients with symptomatic, biopsy-proven malignant to the pleura, or mesothelioma with pleural effusions. Patients must have received and be...
- 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...
- Cardiac ejection fraction ≥ 0.45 by MUGA or echocardiography.
- No requirement for supplemental oxygen and no dyspnea immediately after effusion drainage.
You likely can't join if
- Infection with HIV and active viral replication. Patients with an undetectable viral load on Anti-retroviral Therapy (ART) can be considered for...
- 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...
- Investigational drug use within 30 days before effusion collection.
See the full eligibility criteria
- 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...
- 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...
- Cardiac ejection fraction ≥ 0.45 by 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.
- 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.
- 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.
- 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 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.
- 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...
- Pregnant or lactating females.
- Prior solid organ transplantation
- Patients who, in the opinion of the Investigator, will be non-compliant with study schedules or procedures.
- 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...
- Patients with documented anaphylaxis as a result of penicillin allergy.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.