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Cartesian Therapeutics begins Phase 1/2 trial of Descartes-30 in ARDS
GAITHERSBURG, Md.—Cartesian Therapeutics has reported that the company has initiated a Phase 1/2 clinical trial of its lead RNA-engineered mesenchymal stem cell (MSC) therapy, Descartes-30, in patients with moderate-to-severe acute respiratory distress syndrome (ARDS), including that caused by COVID-19.
The Phase 1/2a study of Descartes-30 is enrolling patients with ARDS at multiple critical care units in the U.S., with enrollment priority given to patients with ARDS due to COVID-19. The first-in-human study aims to determine the safety and preliminary efficacy of Descartes-30 in patients with moderate to severe ARDS. The study, which plans to begin treatment in September, aims to enroll approximately 20 patients prior to initiation of a larger study.
This program is reportedly the first RNA-engineered cell therapy to enter clinical development for ARDS and COVID-19. Descartes-30 is also the first cell therapy to specifically degrade NETs, which are inflammatory webs of DNA and and histones that entrap inflammatory cells, block alveoli and vessels, and drive the pathogenesis of ARDS and COVID-19. NETs are thought to exacerbate the disease by physically occluding air spaces and vessels, leading to reduced oxygenation and increased risk of immune thrombi.
“Patients with ARDS, especially those with COVID-19 ARDS, generate copious amounts of NETs that physically obstruct alveoli and vessels, which leads to respiratory distress, immune-mediated thrombosis and a vicious cycle of inflammation,” said Bruce Levy, M.D., Chief of Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital, Parker B. Francis Professor at Harvard Medical School, and a clinical investigator in the Descartes-30 trial. “We would therefore expect that degrading NETs would improve oxygenation, as well as resolve thrombi and quell inflammation in these patients. If successful, Descartes-30 would be a highly differentiated game-changer within our limited toolkit in managing this exceedingly difficult condition.”
Descartes-30 is an off-the-shelf allogeneic MSC product which is engineered with Cartesian’s RNA Armory cell therapy platform. By expressing a unique combination of DNases that work synergistically, Descartes-30 can eliminate large, macroscopic amounts of NETs within minutes. MSCs are inherently immunomodulatory and naturally travel to the lungs, where they are expected to provide continuous, local delivery of DNases to NET-laden lung tissue.
“We engineered Descartes-30 without genomic modification, and therefore the production of DNases is expected to be time-limited to match the acute nature of ARDS. Given that Descartes-30 will produce DNases locally and transiently, we anticipate that it will have a favorable benefit-to-risk profile,” added Metin Kurtoglu, M.D., Ph.D., chief medical officer of Cartesian. “We also anticipate that these properties will enable Descartes-30 to treat a wide array of NET-related autoimmune and cardiovascular diseases.”