First-In-Human, Open Label, Multicenter Phase I Of Iph4102, First-In-Class Humanized Anti-Kir3dl2 Monoclonal Antibody, In Relapsed/Refractory Cutaneous T-Cell Lymphomas.

TPS2591Background: KIR3DL2 is consistently expressed in all subtypes of Cutaneous T-cell Lymphomas (CTCL), irrespectively of disease clinical stage, with the greatest expression in Sezary Syndrome (SS) and transformed Mycosis Fungoides (MF), two subsets with high unmet need. KIR3DL2 belongs to the killer immunoglobulin (Ig)-like receptor (KIRs) family expressed on minor populations of NK, CD8 and CD4 T cells. IPH4102 is a first-in-class anti-KIR3DL2 monoclonal antibody (mAb). It depletes selectively KIR3DL2-expressing cells. Its modes of action include Antibody-Dependent Cell-Cytoxicity (ADCC) and –Phagocytosis (ADCP). IPH4102 has potent efficacy in non-clinical models, in particular ex vivo autologous assays using primary CTCL cells. Methods: IPH4102-101 (NCT02593045) is a first-in-Human Phase I study of single-agent IPH4102 in relapsed/refractory CTCL. The study has two sequential parts, a dose-escalation followed by cohort expansion. The primary objective is to assess the safety and tolerability of inc...