Company: RNAC
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001453687-25-000060
Chunk: 47

Company: Cartesian Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 47
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 with no prior exposure to biologic therapy that reached Month 12, both were observed to maintain at least a clinically meaningful response with one continuing to maintain minimal symptom expression. 

The safety profile observed in the follow-up portion of the Phase 2b trial was in line with what we reported at the time of our top line data readout as well as the Phase 2a portion of the trial. Of note, there was a Grade 2 upper respiratory infection reported in both the Descartes-08 and placebo groups. There were no other new adverse events, or AEs, reported, including no hypogammaglobulinemia and other infections and no difference in vaccine titers between Descartes-08 and placebo.

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We previously reported that there were three participants in the Phase 2a portion of the trial who were observed to have a response to Descartes-08, but then reverted to baseline, two patients one year after treatment and the other 1.5 years after treatment. As previously reported, there were two participants who were retreated and experienced rapid improvements in clinical scores and maintained minimum symptom expression for up to one year after receiving a second treatment cycle. The time course and magnitude of treatment response upon retreatment were similar to those seen when the participants were first treated. Notably, in the one participant who completed their 12-month retreatment follow-up visit, the duration of response was observed to be longer than that patient’s initial response, and this patient had maintained minimum symptom expression at Month 12. The third retreated participant, at their Month 2 visit, which was 2 weeks after their last Descartes-08 infusion, achieved a 4-point reduction in MG-ADL and 6-point reduction in MGC scores from baseline, without reports of CRS or ICANS. 

Descartes-08 for the Treatment of Systemic Lupus Erythematosus

Overview

We are also developing Descartes-08 for the treatment of SLE, a chronic autoimmune disease that causes systemic inflammation which affects multiple organ systems.

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Background Information About Systemic Lupus Erythematosus

SLE is a chronic, immune-mediated connective tissue disease that can impact nearly all major organ systems. The most common manifestations of SLE are cutaneous and musculoskeletal symptoms, although neurological, gastrointestinal, hematological, and renal symptoms are regularly observed as well. Patients with SLE are at a substantially increased risk of infection and cardiovascular disease, contributing to estimated 10-