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 — DRUG
    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.

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 dose
    Intra-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 weeks
    Descartes-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

Locations (2)

FacilityCityStateZIPSite coordinators
H01- Children's National HospitalWashington D.C.District of Columbia20010
Emily Miller
202-476-4130
Anant Vatsayan, MD (PRINCIPAL_INVESTIGATOR)
H03- Washington University School of MedicineSt LouisMissouri63110
Goddard
314-454-6018

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