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NCT07443020 · ClinicalTrials.gov registry record · Phase 1
Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors
A Phase 1 study, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT07443020 is a Phase 1 study that is actively recruiting participants, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). The registered enrollment target is 10 participants.
The verdict
NCT07443020, a Phase 1 study, is actively recruiting participants, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL locally manufactured adoptive cellular therapy (ACT) product
- DRUG Interleukin-2 (IL-2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-05 |
| Est. Completion | 2038-03 |
| Phase | Phase 1 |
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)34 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07443020
The ClinicalTrials.gov registry entry for NCT07443020 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which locally manufactured adoptive cellular therapy (ACT) product is the first listed.
NCT07443020 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07443020 about?
NCT07443020 is a clinical study titled "Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors". 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 infiltratin...
What is the current status of trial NCT07443020?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2026-05. Estimated completion is 2038-03.
What interventions are being tested in trial NCT07443020?
The interventions under investigation include: locally manufactured adoptive cellular therapy (ACT) product (BIOLOGICAL), Interleukin-2 (IL-2) (DRUG).
Who is sponsoring clinical trial NCT07443020?
This trial is sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), which has 34 total clinical trials registered on ClinicalTrials.gov.
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