Evaluating Descartes-08 Treatment for Youth With Childhood-Onset Autoimmune Diseases Including Lupus, Vasculitis, Myasthenia Gravis, and Dermatomyositis

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of Descartes-08 in children, adolescents, and young adults aged 12 and older with childhood-onset autoimmune diseases including systemic lupus erythematosus, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis. This study is designed as a two-part Phase 12 trial to find the maximum tolerated dose and assess treatment effects in these conditions. The study includes two parts In Part 1, three different doses of Descartes-08 will be given to small groups of participants to establish the maximum tolerated dose. In Part 2, this dose will be administered as six weekly infusions to up to 10 participants in each disease category, given in an outpatient setting. The treatment is delivered by infusion and monitored closely to determine safety and response. Participants will be involved in regular visits during and after treatment to monitor safety and disease status. Assessments include monitoring for serious adverse events at specific days and months, along with blood tests and clinical evaluations over a period extending up to 12 months. Researchers will track the maximum dose tolerated and the frequency of treatment-related adverse events to understand the safety profile of Descartes-08 in these young patients.

Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders