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NexImmune Completes Dosing of First Cohort in Phase 1/2 Clinical Trial of NEXI-001 in Relapsed AML

Current TAP Partner


GAITHERSBURG, MD - September 23, 2020 – NexImmune, a clinical-stage biotechnology company developing unique non-genetically-engineered T cell immunotherapies, announced today that it has completed dosing of the first safety cohort (n=3) in its Phase 1/2 clinical trial for NEXI-001, representing a significant milestone for the Company. NEXI-001 is a cellular product that contains populations of naturally-occurring CD8+ T cells directed against multiple AML-specific antigen targets, and it is the first clinical product generated by the Company’s AIM nanoparticle technology.

The prospective, multi-center, open-label, single-arm, dose-escalating Phase 1/2 study will enroll between 22 to 28 patients. The primary objective is to assess the safety and tolerability of a single infusion of NEXI-001 T cells in patients with AML who have either minimum residual disease (MRD) or relapsed disease after a human leukocyte antigen (HLA)-matched allogeneic stem cell transplant (SCT). 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-001 T cells as measured in blood and bone marrow samples.

This study includes two phases. The initial ‘Safety Evaluation Phase’ will determine the safety and tolerability of a single infusion of NEXI-001 at different dose levels. In the second part of the study, the ‘Dose Expansion Phase,’ investigators will further define safety and will also evaluate the initial efficacy of NEXI-001 T cells at the dose established from the Safety Evaluation Phase.

Press Release

LLS partnered with NexImmune in October 2017 for the development of products like NEXI-001 through our Therapy Acceleration Program® (TAP)