801 PRIME™ IL-15 (RPTR-147): Preliminary clinical results and biomarker analysis from a first-in-human Phase 1 study of IL-15 loaded peripherally-derived autologous T cell therapy in solid tumor patients
Abstract
Background RPTR-147 is a novel autologous non-genetically modified multi-clonal T cell product loaded with an IL15-Fc nanogel. The product was derived from rare peripherally-derived anti-tumor T cell clones that were primed against a multi-antigen cassette containing tumor associated antigens (TAA), known to be over-expressed in specific tumor types. We describe preliminary results from the ongoing first-in-human Phase 1 trial. Methods Autologous anti-TAA T cells are generated with a proprietary dendritic cell priming process and then loaded with an IL15-Fc nanogel. TAAs used in cassette: PRAME, NY-ESO-1, SSX2, Survivin and WT1. Thawed RPTR-147 is delivered by infusion. Pre- and post-treatment biopsies were collected for biomarker analysis by immunohistochemistry (IHC) and transcriptome sequencing. Serial blood collections were obtained for measuring IL-15 pharmacokinetics and pharmacodynamic parameters including plasma cytokine levels and immunophenotyping by flow cytometry. T cell receptor sequencing (TCRSeq) was used to characterize the T cell repertoire from manufactured T cell product and the patient‘s blood. Results Interim clinical and biomarker data from 17 patients with advanced metastatic disease refractory to SOC who received monthly infusions of 20-360 million cells/m², were reviewed (table 1). There were no dose-limiting toxicities and no evidence of cytokine-release syndrome. The 360M/m² dose contained 3X more IL15-Fc than the MTD of systemically administered…
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