The trial (NCT04505813), which is recruiting participants at several sites across the U.S., aims to enroll 22 to 28 patients with relapsed or refractory multiple myeloma, who failed to respond to at least three lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. More information about trial contacts and recruiting sites can be found here.
The study’s main goal is to assess the safety and tolerability of a single infusion of NEXI-002. Additional goals include signs of anti-tumor activity, overall survival, and progression-free survival (time until disease progression or death).
Investigators will also assess the functionality, persistence, and proliferation of NEXI-002 T-cells in blood and bone marrow samples collected from patients.
“While the primary objective in this trial with NEXI-002 is to demonstrate safety and tolerability, we also hope to see initial signs of immunological and clinical activity,” Han Myint, MD, chief medical officer of NexImmune, said in a press release.
NEXI-002 is a new form of cell therapy in which a patient’s own immune T-cells are primed to detect five different molecules found in myeloma cells, without having to be genetically modified.
Like NEXI-001, NexImmune’s lead experimental T-cell therapy for acute myeloid leukemia, NEXI-002 is based on the company’s proprietary Artificial Immune Modulation (AIM) nanotechnology, which uses special nanoparticles to create artificial antigen-presenting cells that activate and direct patient T-cells to attack cancer cells.
NEXI-002 also contains different subsets of patient T-cells, including long-lasting memory T-cells that can remain in the body for long periods of time, potentially helping to increase the therapy’s anti-tumor activity and response duration.
“The AIM technology gives us the unique ability to direct populations of natural T cells against a powerful combination of cell surface and endogenous anti-tumor targets specific to multiple myeloma,” Myint said. “We believe this approach has potential to address primary tumor escape mechanisms, and provide deep and durable clinical responses.”
After its ongoing Phase 1/2 trial (NCT04284228) of NEXI-001, this is the second trial NexImmune has launched to assess its lead proprietary T-cell therapies. Both therapies were cleared to enter clinical testing in the U.S. last year.
“With the initiation of NexImmune’s second clinical trial, we are bringing our transformational technology to another group of patients with a high unmet medical need,” said Scott Carmer, CEO of NexImmune.
“We believe T cell immunotherapies based on the AIM nanoparticle technology represent a highly differentiated and clinically meaningful option for many patients facing life-threatening conditions across the spectrum of cancer, auto-immune and infectious diseases,” he added.
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