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Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

Descartes-08 for Children, Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus, ANCA-associated Vasculitis, Juvenile Myasthenia Gravis, and Juvenile Dermatomyositis

NCT07089121•Cartesian Therapeutics

View on ClinicalTrials.gov

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

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•Parent/Guardian/Patient must be able to give written informed consent

Exclusion Criteria

•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 ;
•Platelets \< 50,000/mm3 (NOTE: platelet transfusions are permissible);
•ALT and/or AST with GGT ≥ 3× upper limit of normal
•Creatine Clearance less than 30mL/min /1.73 m2;
•History of primary immunodeficiency, organ, or allogeneic bone marrow transplant;
•Patients must be seronegative for hepatitis B surface antigen;
•Patients must be seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patients must be tested for the presence of viremia by RT-PCR and must be HCV RNA negative;
+3 more criteria

Locations (1)

H03

St Louis, Missouri, United States

Key Dates

Start Date

January 1, 2026

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

January 9, 2026

Enrollment

ESTIMATED participants

Conditions

Childhood-onset Systemic Lupus ErythematousANCA-Associated Vasculitis (AAV)Juvenile Myasthenia GravisJuvenile Dermatomyositis

Interventions

Descartes-08

DRUG

Contacts

Cartesian Clinical Trials

CONTACT

617-231-8102 trials@cartesiantx.com