380 Preliminary results of an ongoing phase I trial of FT500, a first-in-class, off-the-shelf, induced pluripotent stem cell (iPSC) derived natural killer (NK) cell therapy in advanced solid tumors

• DOI: 10.1136/jitc-2020-sitc2020.0380
• Publication Date: 2020-11-09T19:13:07Z
• Authors: David Hong; Sandip Patel; Manish Patel; Kimberly Musni; Marlisa Anderson; Sarah Cooley; Bahram Valamehr; Wayne Chu
• Keywords: Tolerability

<h3>Background</h3> FT500 is an investigational, off-the-shelf NK cell cancer immunotherapy derived from a human clonal master iPSC line, renewable source which innate effector cells can be mass produced and made available for broad patient access multiple dose administration. has potent cellular cytotoxicity as compared to sourced healthy donors been shown synergize with T anti-PD-1 blockade in preclinical studies.¹ <h3>Methods</h3> being investigated Phase I clinical trial monotherapy combination immune checkpoint inhibitors (ICIs) patients advanced solid tumors lymphomas (ClinicalTrials.gov: NCT03841110). Treatment consists of 2 days lympho conditioning (fludarabine 25 mg/m² cyclophosphamide 300 mg/m²) followed by cycles 3 once weekly doses or combined 1 approved ICIs (nivolumab, pembrolizumab, atezolizumab) who have failed prior ICI therapy. Key translational readouts include safety tolerability, including mediated toxicities anti-product immunogenicity. <h3>Results</h3> 15 relapsed/refractory disease following median 4 therapies were treated escalation, 9 (3 1×108 cells, 6 3×108 cells) each ICI. No limiting toxicities, Grade ³3 related adverse events (AEs), serious AEs, AEs leading treatment discontinuation reported. graft-versus-host (GvHD), cytokine release syndrome (CRS), neurotoxicity (NT) was observed. The most common treatment-emergent &gt;3 nausea (9), fatigue (7), constipation, decreased appetite, lymphocyte count, white blood count (5 each), anemia, neutrophil (4 each). Nine 13 efficacy-evaluable tumor had best response stable iRECIST. One classical Hodgkin lymphoma (cHL) refractory experimental therapy 58% reduction target lesions size plus evidence robust B- T-cell anti product responses observed despite endogenous recovery lympho-conditioning. <h3>Conclusions</h3> Administration up safe tolerable without GvHD, CRS, NT, host rejection. Enrollment non-small lung cHL at per ongoing. <h3>Ethics Approval</h3> This study conducted accordance the Declaration Helsinki all Institutional Review Boards site participating study. Specific approval numbers provided upon request. <h3>Reference</h3> Cichocki F, Bjordahl R, Gaidarova S, Mahmood Rogers P, Ge MQ, Kaufman DS, Cooley Valamehr B, Miller JS. iPSC-derived antibody enhance cytolytic against tumors. <i>Blood</i> 2018;132(Supplement 1):730.