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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study ID
NCT07443020
Phase
PHASE1
Status
Recruiting
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Conditions

  • Malignant Mesothelioma
  • Malignant Pleural Effusion
  • Metastasis to Pleura
  • Pleural Effusion, Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • locally manufactured adoptive cellular therapy (ACT) product — BIOLOGICAL
    Single dose, intrapleural delivery (via indwelling pleural catheter) of adoptive cellular therapy (ACT) product derived from autologous pleural infiltrating T-cells.
  • Interleukin-2 (IL-2) — DRUG
    Low dose Interleukin-2 (IL-2) will also be administered intrapleural at the dose of 20 milliliters (mL) at 1 x 10⁵ International Units (IU)/mL starting approximately 2 hours after ACT infusion and every 8 to 16 hours thereafter, as tolerated, for up to 4 doses (total 8 x 10⁶ IU).

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2033
Completion
Mar 31, 2038

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: locally manufactured adoptive cellular therapeutic (ACT) product
    Single dose, intrapleural delivery (via indwelling pleural catheter) of adoptive cellular therapy (ACT) product derived from autologous pleural infiltrating T-cells. Low dose Interleukin-2 (IL-2) will also be administered intrapleural at the dose of 20 milliliters (mL) at 1 x 10⁵ International Units (IU)/mL starting approximately 2 hours after ACT infusion and every 8 to 16 hours thereafter, as tolerated, for up to 4 doses (total 8 x 10⁶ IU).

Primary Outcome Measure

Document the feasibility of local manufacture of ACT product from drained pleural effusions using the CliniMACS Prodigy® device [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AHN West Penn HospitalPittsburghPennsylvania15224
Patrick Wagner, MD
[email protected]
412-359-3731
AHN Clinical Trial Contact
[email protected]
412-359-3731
David Bartlett, MD (SUB_INVESTIGATOR)
John Lister, MD (SUB_INVESTIGATOR)
Cyrus Khan, MD (SUB_INVESTIGATOR)
Prerna Mewawalla, MD (SUB_INVESTIGATOR)
Santhosh Sadashiv, MD (SUB_INVESTIGATOR)
Anna Kaminsky Koget, MD (SUB_INVESTIGATOR)
Leslie Schlagel, PA-C (SUB_INVESTIGATOR)
Thomas Curley, MD (SUB_INVESTIGATOR)
Shannon Altpeter, PA-C (SUB_INVESTIGATOR)
Albert Donnenberg, PhD (SUB_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By research site
AHN West Penn Hospital· Pittsburgh, PA

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