ClinicalTrials.gov record NCT07089121

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age12 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

An early-phase (Phase 1/2) treatment study of Descartes-08 for people aged 12 and older with childhood-onset SLE, AAV, juvenile myasthenia gravis, or juvenile dermatomyositis. The study has two parts: a dose-finding part with within-patient dose escalation, then a part giving weekly infusions at the determined dose for six weeks. Safety and treatment-related serious adverse events will be tracked with follow-up visits over months.

What it is studying. Whether Descartes-08 can be given safely to young people with specified childhood-onset autoimmune diseases, what dose level is tolerable, and the type and frequency of treatment-related serious adverse events; the study will also collect information on tolerability and signs of efficacy.

What the researchers hope to learn. Establish the maximum tolerated dose of Descartes-08 in this population; describe the type and frequency of treatment-related serious adverse events; gather tolerability and early efficacy information.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Descartes-08

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive infusions of Descartes-08. Part 1 uses intra-patient dose escalation across three dose levels (six infusions total) to find a maximum tolerated dose; Part 2 gives once-weekly infusions for six weeks at the dose found in Part 1. Screening and on-study assessments include blood tests and infection/viral screening (to check counts, liver and kidney function, hepatitis/HIV status, and TB), monitoring for side effects, and scheduled safety visits (including Days 22 and 50 and follow-up visits at months 3, 6, 9, and 12). Participation is conducted in an outpatient setting and requires written informed consent.

How the study is structured. Interventional, non-randomized, open-label Phase 1/2 study with two sequential parts: Part 1 uses intra-patient dose escalation to find a maximum tolerated dose; Part 2 gives once-weekly infusions at that dose for six weeks in disease-specific groups. Participants are followed for safety over several months. No masking (open-label).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on dermatomyositis

This trial is also listed on this site under polymyositis.

Clinical trials59 trials listed for dermatomyositisEvery trial the registry lists for dermatomyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in dermatomyositis researchLatest monthly update: September 2026. Includes: Upadacitinib case reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 14, 2026
Primary completion
December 2027 (estimated)
Study completion
December 2028 (estimated)
Target enrollment
50 participants (estimated)
Last updated on registry
Jul 27, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Cartesian Therapeutics

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (3)

Terms used on this page · explanations by MedicalUpdates.ai

written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
ANC
The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
upper limit of normal
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
bone marrow transplant
A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
principal investigator
The doctor or scientist responsible for running the study at a site or overall.
investigational agent
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
5 half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials