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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorCartesian Therapeutics

About this trial

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

Eligibility criteria

Qualifiers

At least age 12

definitive diagnosis of childhood-onset systemic lupus erythematous, juvenile Myasthenie gravis, juvenile dermatomyositis and AAV

Signs and symptoms of moderate disease

History of systemic treatment

Disqualifiers

Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient;

Abnormal PT/INR or PTT increased > 1.5-fold or patient is on anticoagulation therapy (except in cases of elevated PTT with documented lupus anticoagulant; or in patients who have been on stable doses of anticoagulation therapy for more than 6 months of VTE diagnosis; or in patients on stable doses of anticoagulation therapy for at least 8 weeks of atrial fibrillation diagnosis; these conditions will not be exclusionary unless, in the investigator's opinion, they make participation in the study unsafe);

ANC < 1000 cells/microliter ;

Hemoglobin < 8.0 g/dL ;

Trial design

Treatments tested in this trial

  • Descartes-08

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators