Phase 2 Study of Descartes-08 Treatment for Dermatomyositis and Antisynthetase Syndrome Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are evaluating a new treatment called Descartes-08, which uses a patients own T-cells modified to target a specific protein BCMA, in adults with autoantibody-mediated myositis, including antisynthetase syndrome and dermatomyositis. This phase 2 study is randomized, double-blind, and placebo-controlled to assess the treatments effects on disease improvement, safety, and tolerability. Participants will be randomly assigned to receive either Descartes-08 or a placebo called Plasma-Lyte. The study compares these two groups to see how well Descartes-08 works and how safe it is. The treatment involves autologous T-cell therapy targeting B-cell maturation antigen, aiming to address muscle and skin involvement in these autoimmune conditions. During the study, participants will be monitored over 24 weeks for major improvement using a specific total improvement score. Researchers will assess safety, tolerability, and clinical responses. Participants must provide informed consent and comply with study visits, contraception, and vaccinations as part of the study procedures. The study excludes those with severe lung disease without muscle or skin involvement and other serious conditions, ensuring participants meet strict health criteria.

Descartes-08 in Autoantibody Myositis