Phase I Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (CD40L TIL) for Patients with Oncogene-Driven Advanced Non-Small Cell Lung Cancer (NSCLC)
To determine the effect of a special preparation of cells, called tumor-infiltrating lymphocytes (TIL) stimulated with CD40L, when given with the drug nivolumab, for patients with EGFR, ALK, ROS1, or HER2-genomically altered lung cancer.
Primary Objective: To evaluate the safety of CD40L-augmented TIL with nivolumab administered after progression on prior tyrosine-kinase inhibitors in patients with receptor tyrosine kinase-driven advanced NSCLC. Secondary Objectives: To evaluate the efficacy of TIL administered in patients with receptor tyrosine kinase-driven NSCLC, by assessing the objective response rate (ORR) per iRECIST. To evaluate the efficacy of TIL administered in patients with receptor tyrosine kinase-driven NSCLC by assessing duration of response (DOR). To evaluate the overall survival (OS) of TIL administered in patients with receptor tyrosine kinase-driven NSCLC. Exploratory Objectives: To evaluate the T-cell persistence following TIL and T cells targeting actionable mutations when administered in combination with nivolumab. To characterize the pharmacodynamics and evaluate biomarkers of TIL and nivolumab from tumor tissue and peripheral blood. To explore the proportion of reactivity of autologous T cells to tumor-specific antigens in subjects with NSCLC by assessing the correlation with response and survival
Chemotherapy (NOS); Immunotherapy
Aldesleukin (Interleukin-2); BMS-936558 (Nivolumab); IL-2 (Interleukin-2); Interleukin-2 (); MESNA (); Nivolumab (Opdivo); Proleukin (Interleukin-2); TIL (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
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