OncoMatch/Clinical Trials/NCT07192900
Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease
Is NCT07192900 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including locally manufactured adoptive cellular therapy (ACT) product and Interleukin-2 for malignant pleural effusion.
Treatment: locally manufactured adoptive cellular therapy (ACT) product · Interleukin-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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Mesothelioma
Disease stage
Metastatic disease required
Prior therapy
Must have received: standard of care therapy
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
Cannot have received: cytotoxic anti-cancer therapy
Exception: monoclonal antibody therapy targeting immune checkpoint molecules allowed
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.
Cannot have received: radiation therapy
Exception: monoclonal antibody therapy targeting immune checkpoint molecules allowed
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.
Cannot have received: investigational drug
Investigational drug use within 30 days before effusion collection.
Lab requirements
Blood counts
Hemoglobin < 8 gm/dL or transfusion dependent to maintain ≥ 8 gm/dL; WBC < 2,000/mm3; Platelet count < 100,000/mm3 or transfusion dependent to maintain ≥ 100,000/mm3
Kidney function
Creatinine > 2.0x ULN or calculated creatinine clearance ≤ 40 mL/min
Liver function
AST/SGOT > 2.0x ULN, ALT/SGPT > 2.0x ULN, total bilirubin > 2.0x ULN (unless Gilbert Syndrome >3.0x ULN)
Cardiac function
Cardiac ejection fraction ≥ 0.45 by MUGA or echocardiography; exclusion for myocardial infarction within 6 months, symptomatic coronary artery or valvular disease, or uncontrolled arrhythmia
Cardiac ejection fraction ≥ 0.45 by Multiple-Gated Acquisition (MUGA) or echocardiography. 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. Documented myocardial infarction within 6 months of study participation and/or symptomatic coronary artery or valvular disease or uncontrolled arrhythmia.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- AHN West Penn Hospital · Pittsburgh, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify