Cartesian Therapeutics, Inc. , a Frederick, Maryland-based late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, announced on September 29, 2026 additional positive retreatment data of its lead investigational asset, Descartes-08, in patients with generalized myasthenia gravis (MG), presented during the Myasthenia Gravis Foundation of America (MGFA) Scientific Session of the 2026 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting in Orlando, Florida.
Descartes-08 is Cartesian’s autologous anti-BCMA CAR-T therapy in clinical development for MG and myositis. James F. Howard Jr., MD, a neurologist at the University of North Carolina School of Medicine and investigator in the Phase 2b trial, presented the case series of five retreated patients who experienced clinically meaningful improvements in MG severity scores following a recurrence of MG symptoms at least 12 months after initial treatment.
“There remains a significant unmet need for patients suffering from MG today where current treatment options require patients to utilize chronic immunosuppressants to manage the disease,” said Dr. Howard, Cartesian Clinical Advisor and Professor of Neurology, Medicine, and Allied Health at UNC School of Medicine. “Descartes-08 is designed to target BCMA+ immune cells in MG to potentially provide patients with sustained symptom improvement reflected in clinically significant MG-ADL reductions with the added ability to be re-dosed if symptoms recur. For patients who have already cycled through multiple therapies, the option to retreat a CAR-T cell therapy, in an outpatient setting and without lymphodepleting chemotherapy, represents an exciting potential advancement in the field of MG.”
12-Month Retreatment Results
The data analyzed efficacy, safety, and durability of retreatment in five patients who previously received a full treatment course in the Phase 2 portion of the trial and experienced recurrence of symptoms (MG-ADL ≥6) following 12-month follow-up. Retreatment consisted of six once-weekly infusions, the same regimen as the initial course. Patients had a mean disease duration of 13 years with extensive treatment histories.
- Efficacy: Patients retreated (n=5) at a median of 16.6 months following completion of initial treatment experienced greater improvement in MG symptoms compared to their initial course, with the mean decrease in MG-ADL sustained through 12 months following retreatment. Retreated patients observed an average MG-ADL reduction of 6.6 (±4.2) points and an average MGC reduction of 15 (±6.2) points from baseline at Month 12. All retreated patients experienced a clinically meaningful reduction across MGC (≥3-point) and MG-ADL (≥2-point) scores, and four of five patients maintained the clinically meaningful MG-ADL reduction through Month 12.
- Safety: Consistent safety data supports potential retreatment following recurrence of MG symptoms, with clinical benefit observed and no new safety concerns. Descartes-08 was generally well-tolerated through Month 12 following retreatment, with adverse events transient and mild. No serious adverse events were reported during retreatment, and notably, there were no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), cytopenias, or hypogammaglobulinemia.
“Descartes-08’s clinical data generated to date has demonstrated the potential for meaningful clinical responses that persist through 12 months following the completion of an initial course of treatment, with the ability to be re-dosed if needed. Unlike currently approved therapies that generally require cyclical dosing to maintain effect, Descartes-08 is being developed with the goal of providing sustained clinical benefit following a finite course of treatment,” said Carsten Brunn, PhD, President and Chief Executive Officer of Cartesian. “We believe the combination of sustained symptom improvement, the ability to retreat if symptoms return, and the quality-of-life benefits of outpatient administration without lymphodepleting chemotherapy sets Descartes-08 apart and has the potential to meaningfully change the way MG is treated. These data strengthen our conviction in Descartes-08 as we approach topline results from our Phase 3 AURORA trial, expected in the first quarter of 2027.”
About Descartes-08
Descartes-08, Cartesian’s lead cell therapy candidate, is an investigational, autologous CAR-T product targeting BCMA in clinical development for generalized MG and myositis, specifically dermatomyositis and antisynthetase syndrome. In contrast to conventional DNA-based CAR T-cell therapies, Cartesian’s CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the FDA for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis.
About Cartesian Therapeutics
Cartesian Therapeutics is a late clinical-stage company pioneering cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a CAR-T in Phase 3 clinical development for patients with generalized myasthenia gravis, Phase 2 clinical development in myositis, specifically dermatomyositis and antisynthetase syndrome, and in Phase 1/2 clinical development for pediatric autoimmune diseases, including juvenile dermatomyositis.
