Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders
NCT07089121 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-04-08
Summary
Safety, tolerability and efficacy of Descarte-08 in children, adolescents and young adults with childhood-onset systemic lupus erythematosus, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis
Conditions
- Childhood-onset Systemic Lupus Erythematous
- ANCA-Associated Vasculitis (AAV)
- Juvenile Myasthenia Gravis
- Juvenile Dermatomyositis
Interventions
- DRUG
-
Descartes-08
In part 1, three different doses will be administered to 3 participants with either disease indication to establish maximum tolerated dose In part 2, the MTD established in Part-1 will be administered as six once-weekly infusions to up to 10 participants per each of four baskets (cSLE, AAV, JDM and JMG) in an outpatient setting.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-14
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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