Cartesian Therapeutics (NASDAQ:RNAC) provided an update on its Descartes-08 program, a first-in-class autologous mRNA-engineered CAR-T cell therapy targeting B-cell maturation antigen (BCMA) for the treatment of autoimmune diseases, and outlined key 2026 priorities.
Enrollment remains on track in the randomized, double-blind Phase 3 AURORA trial evaluating Descartes-08 in approximately 100 participants with acetylcholine receptor antibody-positive (AChR Ab+) myasthenia gravis (MG).
The study administers six once-weekly outpatient infusions without the need for lymphodepleting preconditioning chemotherapy.
The primary endpoint is a ≥3-point improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Month 4.
The U.S. Food and Drug Administration has accepted an Investigational New Drug application for the seamless adaptive Phase 2 TRITON trial of Descartes-08 in myositis.
The study is designed to enroll up to 50 participants, incorporating an interim analysis after the first 10 patients to inform the potential for a single pivotal trial.
The company anticipates initiating this trial in the first half of 2026.
Additionally, Cartesian has initiated the Phase 1/2 HELIOS trial evaluating Descartes-08 in pediatric patients with juvenile dermatomyositis, further expanding the program's footprint across autoimmune indications.
Supporting the clinical advancement, two peer-reviewed publications in Nature Medicine detailed the mechanism of action and long-term durability of Descartes-08.
In a biologic-naïve subgroup (n=7), 57% of patients achieved minimal symptom expression at Month 6, with responses sustained through Month 12, accompanied by a median prednisone dose reduction of 55% at Month 12.
Across studies, Descartes-08 has demonstrated a favorable safety profile with no cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) reported.
The company ended 2025 with a cash position expected to provide runway into mid-2027, positioning Cartesian to advance multiple Descartes-08 studies and potentially deliver registrational data across serious autoimmune indications.