Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders
Part of paid clinical trials in Washington D.C., District of Columbia.
- Sponsor
- Cartesian Therapeutics
- Study ID
- NCT07089121
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- ANCA-Associated Vasculitis (AAV)
- Childhood-onset Systemic Lupus Erythematous
- Juvenile Dermatomyositis
- Juvenile Myasthenia Gravis
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Descartes-08 — DRUGIn 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.
Study Details
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
Key Dates
- Start date
- Jan 14, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part 1: Decartes-08 to establish Maximum tolerated doseIntra-patient dose escalation arm with three dose levels over the course of six infusions of cell product.
- Experimental: Part 2: Decartes-08 infusions once weekly for 6 weeksDescartes-08 infusions at the maximum tolerated dose level from Part 1.
Primary Outcome Measure
Maximum tolerated dose in Part 1, type and frequency of treatment related SAE's in Part 2 [ Time Frame: Days 22 and 50 for Part1 , Days 22, 50 and Months 3,6,9 and 12 for part 2 ]
Central Contacts
- Cartesian Clinical Trials617-231-8102
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| H01- Children's National Hospital | Washington D.C. | District of Columbia | 20010 | Anant Vatsayan, MD (PRINCIPAL_INVESTIGATOR) |
| H03- Washington University School of Medicine | St Louis | Missouri | 63110 |
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