Journal article
Fast tumor-infiltrating lymphocytes (TILs) for treatment of metastatic cancer with malignant pleural effusion: Protocol for the phase I regional immuno-oncology trial (RIOT)-4
Surgical oncology insight, v 3(3), 100277
Sep 2026
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Abstract
Malignant pleural effusions (MPE) are a manifestation of advanced malignancy associated with poor prognosis, limited survival, and significant symptom burden. Current management is largely palliative and focused on fluid control rather than disease-modifying regional therapy. Malignant pleural effusions frequently contain abundant pleural infiltrating T (PIT) cells, representing an accessible and clinically feasible starting material for rapid autologous adoptive cellular therapy (ACT). RIOT-4 is a single-center, Phase I translational feasibility and safety clinical trial evaluating intrapleural administration of a locally manufactured PIT-derived ACT product generated using a closed GMP-compliant CliniMACS Prodigy® platform. The primary objective is to evaluate the safety and feasibility of intrapleural administration of a locally manufactured Fast TIL product in combination with low-dose intrapleural interleukin-2 (IL-2). Secondary objectives include ACT product characterization, immune profiling of pleural fluid and peripheral blood, T cell receptor (TCR) repertoire dynamics, cytokine/secretome analysis, spatial immune mapping, and preliminary clinical response assessment. This trial leverages institutional GMP cellular therapy infrastructure to generate a rapid, autologous Fast TIL product from pleural effusion as a novel compartmental immunotherapy strategy for patients with malignant pleural disease.
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Details
- Title
- Fast tumor-infiltrating lymphocytes (TILs) for treatment of metastatic cancer with malignant pleural effusion: Protocol for the phase I regional immuno-oncology trial (RIOT)-4
- Creators
- Patrick L. Wagner (Corresponding Author) - Drexel UniversityCatherine R. Lewis - Allegheny Health NetworkPaige O. Mirsky - Allegheny Health NetworkOleksii Kucherenko - Allegheny Health NetworkChristopher Sherry - Allegheny Health NetworkBrett M. Szeligo - Allegheny Health NetworkShannon Altpeter - Allegheny Health NetworkSamantha Devine - Allegheny Health NetworkVera S. Donnenberg - University of PittsburghNeda Dadgar - Allegheny Health NetworkDavid L. Bartlett - Drexel UniversityAlbert D. Donnenberg - Allegheny Health Network
- Publication Details
- Surgical oncology insight, v 3(3), 100277
- Publisher
- Elsevier
- Number of pages
- 6
- Grant note
- Department of Defense: HT9425-23-PRCRP-TTSA, CA230972, BC032981, BC044784, W81XWH-12-1-0415, BC132245_ W81XWH-14-0258, W81XWH2210009_BC210533, W81XWH2211069_ BC211396, BC240179 National Institute of Health (NIH): R37CA232209
This work was supported by Department of Defense CDMRP Funding opportunity number: HT9425-23-PRCRP-TTSA, as well as grants CA230972, BC032981, BC044784, W81XWH-12-1-0415, BC132245_ W81XWH-14-0258, W81XWH2210009_BC210533, W81XWH2211069_ BC211396, and BC240179 from the Department of Defense, and the R37CA232209 from the National Institute of Health (NIH).
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Surgery; General Internal Medicine
- Web of Science ID
- WOS:001845615400001
- Scopus ID
- 2-s2.0-105046496974
- Other Identifier
- 991022201735804721