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

This study is testing a treatment called Descartes-08 for children, adolescents, and young adults (age 12 and older) who have certain autoimmune disorders. These include childhood-onset systemic lupus erythematosus (cSLE), ANCA-associated vasculitis (AAV), juvenile myasthenia gravis, and juvenile dermatomyositis. The study aims to find the safest dose of Descartes-08 and see how well it works. Participants will receive Descartes-08 as six weekly infusions. To join, you must have a confirmed diagnosis of one of these conditions, have moderate disease symptoms, and have a history of systemic treatment. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 50 participants. It will involve testing different doses of Descartes-08 in the first part, then giving the established dose to groups of up to 10 participants for each condition.
What's involved
Participants in Part 1 will receive three different doses of Descartes-08. Participants in Part 2 will receive six once-weekly infusions of Descartes-08.
Compensation
Not stated in the trial record.
Follow-up
Participants in Part 1 will be followed for safety at Days 22 and 50. Participants in Part 2 will be followed for safety at Days 22, 50, and Months 3, 6, 9, and 12.

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NCT07089121

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

Recruiting
PHASE1Ages 12+InterventionalTreatment
Cartesian Therapeutics
~50 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Descartes-08

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose in Part 1, type and frequency of treatment related SAE's in Part 2
Measured over Days 22 and 50 for Part1 , Days 22, 50 and Months 3,6,9 and 12 for part 2
+1 more outcome measured

Conditions

Childhood-onset Systemic Lupus Erythematous
ANCA-Associated Vasculitis (AAV)
Juvenile Myasthenia Gravis
Juvenile Dermatomyositis

Explore related trials

Antineutrophil cytoplasmic antibody positive vasculitisDermatomyositisMyasthenia GravisSystemic Lupus Erythematosus

Where it's being run

3 sites across 3 states
District of Columbia1
Missouri1
Ohio1

Who to contact

Cartesian Clinical Trials
[email protected]
617-231-8102
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Maximum tolerated dose in Part 1, type and frequency of treatment related SAE's in Part 2Days 22 and 50 for Part1 , Days 22, 50 and Months 3,6,9 and 12 for part 2

    The primary endpoint for Part-1 is the Maximum Tolerated Dose (MTD), defined as the Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity (DLT), i.e. at which 3 patients received all 6 weekly infusions without a DLT by Day 50; or 6 patients received 3 weekly infusions with no more than 1 patient having a DLT by Day 50. The primary endpoint for Part-2 is the type and frequency of treatment-related SAEs. This will be assessed on Days 22, 50 and Months 3,6,9,12

  • Maximum Dose ToleratedDays 2250 for Part 1, Days 11,50, month 3 for part 2 in addition to months, 4,6,9,12

    The primary endpoint for Part-1 is the Maximum Tolerated Dose (MTD), defined as the Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity (DLT), i.e. at which 3 patients received all 6 weekly infusions without a DLT by Day 50; or 6 patients received 3 weekly infusions with no more than 1 patient having a DLT by Day 50. The primary endpoint for Part-2 is the type and frequency of treatment-related SAEs.