Company: RNAC
Filing Date: 2025-11-13
Form Type: 8-K
Source: 0001453687-25-000123
Chunk: 2

Company: Cartesian Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 8-K
Item: Item 8.01
Chunk 2
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 the planned expansion of Descartes-08 into myositis. The Company plans to initiate a seamless adaptive clinical trial design which provides a potential opportunity for a single pivotal trial planned to commence in the first half of 2026.

The randomized, double-blind, placebo-controlled Phase 2 trial in myositis is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six weekly outpatient infusions without preconditioning chemotherapy in up to 50 patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome. The primary endpoint is expected to assess safety and efficacy of Descartes-08 compared to placebo added to standard of care in patients with myositis at Week 24. An interim analysis is expected after ten patients are enrolled and reach the primary endpoint, at which point sample size assumptions will be revised to what is necessary to support a seamless pivotal trial pending Food and Drug Administration review based on the preliminary efficacy data available at such time. The Company plans to file an investigational new drug application for this trial by the end of 2025.

On November 13, 2025, the Company also reported preliminary results from the Phase 1 dose escalation trial designed to assess safety and tolerability of outpatient administration of Descartes-15 in patients with multiple myeloma. In this trial, no significant adverse events or dose-limiting toxicities were reported in any participants (n=3). The only Descartes-15-related adverse event was a grade 2 hypotension occurring after the first two infusions.

At this time, the Company plans to pause further development of Descartes-08 in SLE, including enrollment in the ongoing Phase 2 trial, and Descartes-15 to prioritize opportunities in Descartes-08 in MG, currently in Phase 3, and myositis.

Forward-Looking Statements

Any statements in this Current Report on Form 8-K about the future expectations, plans and prospects of the Company, including without limitation, statements regarding the ability of the Company’s product candidates to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the potential of Descartes-08, Descartes-15, or any of the Company’s other product candidates to treat myasthenia gravis, juvenile myasthenia gravis, systemic lupus erythematosus, juvenile systemic lupus erythematosus, juvenile dermatomyositis, anti-ne