NEW YORK – Cartesian Therapeutics expects to launch a randomized, controlled Phase III trial, dubbed AURORA, to evaluate its investigational cell therapy for myasthenia gravis in the first half of the year.
In the trial, about 100 patients with myasthenia gravis will receive six weekly infusions of either a placebo or Descartes-08, the company's lead candidate and an autologous mRNA-engineered CAR T-cell therapy that targets B-cell maturation antigen (BCMA) cell-surface proteins.
The Frederick, Maryland-based biotech will monitor whether patients who receive Descartes-08 improve by at least three points on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale within four months posttreatment, compared to those on placebo. In a Phase IIb trial, Descartes-08-treated patients on average improved by 5.5 points in this time frame. Patients in the Phase IIb trial also tolerated the treatment well, a finding that supports the outpatient administration of the cell therapy without the need for lymphodepleting chemotherapy, according to Cartesian.
Separately, the company continues to enroll patients into an open-label Phase II trial, in which it is evaluating Descartes-08 in systemic lupus erythematosus and in which it is also administering the treatment in the outpatient setting. Cartesian anticipates a data readout from this clinical trial in the second half of the year.
Cartesian said it plans to kick off a Phase II basket trial of Descartes-08 in pediatric patients with certain autoimmune diseases, including juvenile dermatomyositis, later this year.
The company's cash resources are expected to support its operations into mid-2027 and allow it to complete the Phase III trial of Descartes-08 in myasthenia gravis.