Company: RNAC
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001453687-25-000060
Chunk: 40

Company: Cartesian Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 40
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 similar to the time course and magnitude of treatment response observed when the participants were first treated. Four of the seven remaining participants from the Phase 2a portion of the trial maintained clinically meaningful responses for at least one year following initial dosing.

We plan to commence our Phase 3 AURORA trial of Descartes-08 in patients with MG in the first half of 2025. The randomized, double-blind, placebo-controlled Phase 3 AURORA trial is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six weekly outpatient infusions without preconditioning chemotherapy in approximately 100 participants with acetylcholine receptor autoantibody positive, or AChR Ab+, MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG-ADL score of three points or more at Month 4 compared to placebo. Secondary endpoints will assess safety and tolerability and the proportion of participants with a reduction of four points or more in MGC score, as well as improvements in other validated MG severity scales, including Quantitative MG, QMG, and MG Quality of Life Revised Scale, or MG-QoL-15R. In January 2025, we received written agreement from the FDA under the Special Protocol Assessment, or SPA, process on the overall design of our planned AURORA trial. The SPA agreement indicates that the FDA has determined that the proposed trial design is acceptable to support a future Biologics License Application, or BLA, for Descartes-08 in MG, subject to the ultimate outcome of the trial.

Descartes-08 for the Treatment of Other Autoimmune Diseases

We are also developing Descartes-08 for the treatment of other autoimmune diseases. In July 2024, the first patient was dosed in our Phase 2 trial of Descartes-08 for the treatment of systemic lupus erythematosus, or SLE, a chronic autoimmune disease that causes systemic inflammation affecting multiple organ systems. A data readout of this trial is expected in the second half of 2025.

In December 2024, we filed an amendment to the investigational new drug application, or IND, for a pediatric basket trial for juvenile dermatomyositis, or JDM, juvenile SLE, juvenile MG, anti-neutrophil cytoplasmic antibody-associated vasculitis, as well as other conditions. Our Phase 2 basket trial in pediatric patients is expected to initiate in the second