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An Open-Label, Multi-Center Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T cells in Patients with Advanced Non-Small Cell Lung Cancer (CHIRON)
This is a first-in-human, open-label, phase I/IIa study to characterise the safety and clinical activity autologous clonal neoantigen T cells (cNeT) administered intravenously in adults with advanced non-small cell lung cancer (NSCLC).
Primary Objective: -To assess the safety and tolerability of ATL001 therapy. Secondary Objective: -To evaluate the clinical efficacy of ATL001 using RECIST v1.1 and imRECIST. Exploratory Objectives: -To evaluate the persistence, phenotype and functionality of NAR-T cells and to explore possible relationships with clinical outcomes. -To evaluate potential biomarkers of clinical activity and factors affecting response. -To evaluate manufacturing rate and factors that may affect the quality of ATL001. -To evaluate the utility of a bespoke plasma ctDNA assay. -To evaluate pleural fluid as a source of T cells and free tumor DNA.
ATL001 (); IL-2 (Interleukin-2); Pembrolizumab (Keytruda); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)