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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 12 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe Descartes-08 is, how well people tolerate it, and whether it works. It is for children, teens, and young adults age 12 or older with certain autoimmune diseases, where the body's defenses attack healthy tissue.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 12 years old.
- Have a confirmed diagnosis of childhood-onset lupus, juvenile myasthenia gravis, juvenile dermatomyositis, or ANCA-associated vasculitis. These diseases can affect organs, muscles, skin, or blood vessels.
- Have signs and symptoms of moderate disease.
- Have had treatment that works throughout the body.
- The parent, guardian, or patient must be able to give written consent.
Who can't join
- Have a poorly controlled long-term illness, a mental illness, or another abnormal test result that makes joining unsafe or difficult. Significant active heart or lung disease unrelated to the study disease may also exclude you; asthma or COPD controlled with inhaled medicines is allowed.
- Have certain abnormal blood-clotting tests, take blood thinners, or have had a blood clot in the past 3 months. Some exceptions apply to clotting tests and stable blood-thinner use if the study doctor considers it safe.
- Have low blood counts: infection-fighting cells below 1,000, hemoglobin below 8 g/dL, or platelets below 50,000. Platelet transfusions are allowed. Certain liver tests at least 3 times normal or kidney clearance below 30 also exclude you.
- Have a history of an immune weakness you were born with, an organ transplant, or a bone marrow transplant from a donor.
- Have a positive hepatitis B surface antigen test, hepatitis C virus in the blood, HIV, active tuberculosis, or a positive tuberculosis screening test. Serious repeated infections or an active infection that affects participation may also exclude you.
- Have had cancer needing treatment in the past 3 years. Exceptions include successfully treated squamous or basal cell skin cancer, or breast or colon cancer removed by surgery without added chemotherapy or radiation.
- Have received an experimental drug within 4 weeks before screening, or within the time needed for its level to drop by half 5 times, whichever is longer.
- Have received a live vaccine within 4 weeks before Day 1, or plan to receive one during the study. mRNA vaccines and the Janssen COVID-19 vaccine are not live vaccines.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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; * History of positive HIV or positive HIV at screening; * Active tuberculosis or positive QuantiFERON test at screening; * Any other laboratory abnormality that, in the opinion of the investigator, may jeopardize the subject's ability to participate in the study; 23. Any active significant cardiac or pulmonary disease not related to the primary indication as determined by principal investigator and medical monitor Note: Patients with asthma and COPD controlled with inhaled medications are allowed; 24. Any arterial or venous thromboembolic events in the past 3 months; 25. History of malignancy that required treatment in the past 3 years except for successfully-treated squamous cell and/or basal cell carcinoma of the skin and/or breast or colon cancer that is surgically removed and did not require adjuvant chemotherapy or radiotherapy; 26. Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer); 27. Receipt of a live vaccination within 4 weeks prior to baseline (Day 1) or intent to receive live vaccination during the study (Note: mRNA-based vaccines such as those against SARS-CoV-2 are not considered live; likewise, the Janssen Covid-19 vaccine is not live); 28. History of significant recurrent infections or any active infection that may interfere with the patient's participation in the opinion of the investigator; 29. Any known psychiatric illness that may interfere with the patient's participation in the study in the opinion of the investigator.
Study sites (3)
DC
- H01- Children's National Hospital · Washington D.C., DC 20010Emily Miller · Study contact · 202-476-4130 · ejmiller@childrensnational.orgAnant Vatsayan, MD · Principal investigatorMore trials in Washington D.C.
MO
- H03- Washington University School of Medicine · St Louis, MO 63110Grace Goddard · Study contact · 314-454-6018 · pedshemonctrialreferral@wustl.eduMelissa Mavers, MD · Principal investigatorMore trials in St Louis
OH
- Cincinnati Children's Hospital Medical Center · Cincinnati, OH 45229Megan Quinlan-Waters · Study contact · Megan.Quinlan-Waters@cchmc.orgHermine Brunner, MD · Principal investigatorMore trials in Cincinnati