Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07443020 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors

Study acronym: RIOT 4B
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened
    • Start date: Mar 2026 to May 2026
    • Site details revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07443020
Lead Sponsor Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators: AHN Cancer Institute (AHNCI)
Conditions
(from sponsor)
Malignant Pleural Effusion, Malignant Mesothelioma, Pleural Effusion, Malignant, Metastasis to Pleura
Related terms Mesothelioma, Malignant, Pleural Effusion, Malignant
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov