A Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of Descartes-08 in Patients With Dermatomyositis and Antisynthetase Syndrome
This is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy, safety and tolerability of an autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA) in patients with autoantibody-mediated myositis, including antisynthetase syndrome (ASyS) and dermatomyositis (DM).
• Confirmed diagnosis of one of the following:
⁃ Dermatomyositis (DM): Probability score ≥55% on the 2017 EULAR/ACR (European Alliance of Associations of Rheumatology/ American College of Rheumatology) criteria for classification of dermatomyositis (corresponding to diagnosis of 'probable or definite' DM). OR Antisynthetase Syndrome (ASyS): Diagnosis based on ACR/EULAR Classification Criteria (1).
• Participants must have dermatomyositis or antisynthetase syndrome with muscle and/or skin involvement.
• Refractory or intolerance to standard therapy.
• Stable background immunosuppressive therapy for ≥8 weeks.
• Adequate hematologic, renal, hepatic, and pulmonary function (SpO₂ ≥92% on room air).
• Informed consent, compliance with visits, contraception, and vaccinations required.