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Cell therapy Descartes-08 tested in teens with lupus and other autoimmune diseases

NCT ID NCT07089121

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This early-stage trial is testing Descartes-08, a cell therapy made from modified immune cells, in 50 young people aged 12 and older with four autoimmune diseases: childhood-onset lupus, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis. The study has two parts: first, finding the safest dose, then giving that dose weekly for six weeks to see how safe and tolerable it is. The goal is to gather safety data, not yet to prove the treatment works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Descartes-08 (a cell therapy using modified immune cells)
What this could lead to
If it works, this could point toward a new treatment option for young people with certain autoimmune diseases that are hard to control with current therapies.
What could go wrong
This is an early Phase 1/2 trial with only 50 participants, so it is primarily testing safety and dosing. It may not show clear benefit, and cell therapies can have serious side effects like infusion reactions or immune overactivation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • H01- Children's National Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • H03- Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

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