Cartesian reveals long-term mid-stage data for cell therapy in myasthenia gravis

Title

"Cartesian Therapeutics Reports Promising Long-Term Results for Descartes-08 CAR-T Cell Therapy in Myasthenia Gravis"

Keywords

Cartesian Therapeutics
Descartes-08
Myasthenia Gravis
CAR-T cell therapy
phase 2b trial results
RNA-based therapy
autoimmune disease treatment
BCMA-targeted therapy
durable clinical response
MG-ADL improvement

Key Facts

- Therapy Overview:
Cartesian Therapeutics' Descartes-08 is an RNA-based CAR-T therapy targeting B-cell maturation antigen (BCMA) to treat generalized myasthenia gravis (MG). It avoids preconditioning chemotherapy, enabling outpatient administration1 3 6.

- Clinical Results:
Phase 2b clinical trial data demonstrated sustained efficacy, with a 4.8-point reduction in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores at 12 months. Patients without prior biologic therapy exposure achieved a higher improvement (7.1-point MG-ADL reduction)3 6.

- Durability of Response:
83% of participants maintained clinically meaningful response at 12 months. Among biologic-naïve patients, 57% achieved minimum symptom expression at Month 123 6.

- Safety Profile:
No cases of cytokine release syndrome or neurotoxicity were reported, solidifying Descartes-08 as a safe and well-tolerated option3 6 10.

- Regulatory Status:
The therapy has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the FDA. A Phase 3 trial (AURORA) is planned for 2025 to further evaluate its efficacy and safety6 9.

- Potential Impact:
Descartes-08 offers a potentially transformative treatment for myasthenia gravis, providing longer-term symptom remission with a single treatment course. It also sets the foundation for applications in other autoimmune diseases, such as lupus1 3 4.