This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.
LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
adoptive cell therapy (ACT) with autologous TIL therapy
PD-L1 antagonist monoclonal antibody
University of California San Diego, Moores Cancer Center
La Jolla, California, United States
University of California, Los Angeles, Santa Monica Hematology/Oncology
Los Angeles, California, United States
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, United States
Objective Response Rate
To evaluate efficacy using the objective response rate (ORR)
Time frame: A maximum of 24 months
≥ Grade 3 Treatment-Emergent Adverse Event
To evaluate the safety as measured by any ≥ Grade 3 treatment-emergent adverse event (TEAE) rate
Time frame: A maximum of 24 months
Duration of Response
To further evaluate efficacy such as the duration of response (DOR)
Time frame: A maximum of 24 months
Progression Free Survival
To further evaluate efficacy such as progression free survival (PFS)
Time frame: A maximum of 24 months
Overall Survival
To further evaluate efficacy such as overall survival (OS)
Time frame: A minimum of 5 years
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Karmanos Cancer Institute
Detroit, Michigan, United States
Morristown Medical Center Atlantic Hematology Oncology
Morristown, New Jersey, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Washington Medical Center
Seattle, Washington, United States