FREDERICK, Md. — January 9, 2026 — Leads & Copy — Cartesian Therapeutics, Inc. (NASDAQ: RNAC), a clinical-stage biotechnology company, announced updates on its cell therapy pipeline targeting autoimmune diseases, highlighting recent progress and 2026 strategic priorities.
Enrollment remains on track in the Phase 3 AURORA trial of Descartes-08 in myasthenia gravis (MG). The FDA accepted the investigational new drug (IND) application for Descartes-08 in myositis, with a seamless adaptive clinical trial expected to commence in the first half of 2026. The Phase 1/2 pediatric trial of Descartes-08 in juvenile dermatomyositis has been initiated. Current cash resources are expected to support planned operations into mid-2027, including the completion of the Phase 3 trial for Descartes-08 in myasthenia gravis.
Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian, said the company is entering 2026 with strong momentum, focusing on advancing Descartes-08 across multiple indications. The ongoing Phase 3 AURORA trial is for the treatment of MG, where Descartes-08 demonstrated deep and sustained responses in the Phase 2b trial. Brunn expressed confidence that Descartes-08 could be a meaningful addition to the MG treatment landscape, given its favorable safety profile supporting outpatient administration.
The company is also planning to initiate a Phase 2 trial in myositis in the first half of 2026, potentially leading to a single pivotal trial after an interim analysis of the first ten participants enrolled. Cartesian Therapeutics also continues to develop next-generation agents to improve potency and therapeutic targeting and is exploring enhanced cell therapy delivery through in-vivo platforms.
The Phase 3 AURORA trial assesses Descartes-08 versus placebo in approximately 100 participants with acetylcholine receptor autoantibody positive (AChR Ab+) MG. Descartes-08 is administered as six once-weekly outpatient infusions without preconditioning chemotherapy. The primary endpoint is the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo. Nature Medicine included the trial on its “Eleven clinical trials that will shape medicine in 2026” list.
In November 2025, the company announced plans to expand into myositis. The planned Phase 2 seamless adaptive clinical trial in myositis (TRITON) is designed to assess Descartes-08 versus placebo in up to 50 participants with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome. The primary endpoint will assess safety and efficacy of Descartes-08 compared to placebo added to standard of care in participants with myositis at Week 24. An interim analysis is expected after ten participants are enrolled and reach the primary endpoint.
Beyond myositis in adult indications, the Phase 1/2 (HELIOS) pediatric trial of Descartes-08 has been initiated in children and young adults with autoimmune diseases, including juvenile dermatomyositis (JDM). The FDA previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM.
Two peer-reviewed journal articles were published in Nature Medicine detailing the mechanism of action of Descartes-08 and reiterating data from the Phase 2b trial of Descartes-08 in patients with MG. The mechanism of action article observed that transient targeting of BCMA with Descartes-08 achieved precision retuning of autoreactivity in MG. The second publication outlines deep and durable responses observed through 12 months after a single course of therapy. The median reduction in prednisone daily dose was 55% at Month 12.
The company continues to evaluate the potential of enhanced delivery platforms for its cell therapies and is exploring optimizing in-vivo delivery of Descartes-08, Descartes-15, and next-generation agents. The recent appointment of Adrian Bot, M.D., Ph.D., to the Company’s Board of Directors supports this strategic expansion.
Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous chimeric antigen receptor T-cell therapy (CAR-T) product targeting B-cell maturation antigen (BCMA) in clinical development for generalized myasthenia gravis (MG) and myositis. It has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis.
Cartesian Therapeutics is pioneering cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is in Phase 3 clinical development for patients with generalized myasthenia gravis and has plans to initiate a Phase 2 trial in myositis.
Contact:
Megan LeDuc
Associate Director of Investor Relations
megan.leduc@cartesiantx.com
David Rosen
Argot Partners
david.rosen@argotpartners.com
Source: Cartesian Therapeutics
