GAITHERSBURG, MD -- October 6, 2020 – NexImmune, a clinical-stage biotechnology company developing a portfolio of unique non-genetically-engineered T cell immunotherapies, announced today that it has dosed the first patient in its Phase 1/2 clinical trial for NEXI-002. NEXI-002 is a patient-derived cellular product that contains populations of naturally-occurring CD8+ T cells directed against several multiple myeloma (MM)-specific antigen targets. It is the second clinical product NexImmune has generated with its AIM nanoparticle technology.
Investigators will enroll between 22 to 28 patients in the prospective, multi-center, open-label, single-arm Phase 1/2 study. The trial’s primary objective is to assess the safety and tolerability of a single infusion of NEXI-002 T cells in patients with MM who have failed at least three prior lines of therapy. Secondary objectives include signals of anti-tumor activity, progression-free survival (PFS) and overall survival (OS). Additional analysis will assess the in vivo persistence, proliferation, functionality and T cell receptor (TCR) repertoire of NEXI-002 T cells as measured in blood and bone marrow samples. Clinical sites participating in this trial include Dana Farber Cancer Institute, Karmanos Cancer Institute, MD Anderson Cancer Center, City of Hope Comprehensive Cancer Center and Memorial Sloan Kettering Cancer Center.
LLS partnered with NexImmune in October 2017 for the development of products like NEXI-002 through our Therapy Acceleration Program® (TAP).