Childhood-onset Systemic Lupus ErythematousPhase 1/2NCT07089121
Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders
A Phase 1/2 study testing Descartes-08 in people with Childhood-onset Systemic Lupus Erythematous and ANCA-Associated Vasculitis (AAV), run by Cartesian Therapeutics at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV), Juvenile Myasthenia Gravis
- What is being tested?
- Descartes-08
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jan 2026to Dec 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Megan Quinlan-Waters, Megan.Quinlan-Waters@cchmc.org
Hermine Brunner, MD
- Recruiting
H03- Washington University School of Medicine
St Louis, Missouri, 63110
Grace Goddard, 314-454-6018, pedshemonctrialreferral@wustl.edu
Melissa Mavers, MD
- Recruiting
H01- Children's National Hospital
Washington D.C., District of Columbia, 20010
Emily Miller, 202-476-4130, ejmiller@childrensnational.org
Anant Vatsayan, MD
About this study
Official title: Descartes-08 for Children, Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus, ANCA-associated Vasculitis, Juvenile Myasthenia Gravis, and Juvenile Dermatomyositis
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
- Conditions
- Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV), Juvenile Myasthenia Gravis, Juvenile Dermatomyositis
- Being tested
- Descartes-08
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descartes-08Drug
In part 1, three different doses will be administered to 3 participants with either disease indication to establish maximum tolerated dose In part 2, the MTD established in Part-1 will be administered as six once-weekly infusions to up to 10 participants per each of four baskets (cSLE, AAV, JDM and JMG) in an outpatient setting.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Decartes-08 to establish Maximum tolerated dose | Experimental | Intra-patient dose escalation arm with three dose levels over the course of six infusions of cell product. Receives: Drug: Descartes-08 |
| Part 2: Decartes-08 infusions once weekly for 6 weeks | Experimental | Descartes-08 infusions at the maximum tolerated dose level from Part 1. Receives: Drug: Descartes-08 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose in Part 1, type and frequency of treatment related SAE's in 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
Measured: Days 22 and 50 for Part1 , Days 22, 50 and Months 3,6,9 and 12 for part 2
Maximum Dose Tolerated
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.
Measured: Days 2250 for Part 1, Days 11,50, month 3 for part 2 in addition to months, 4,6,9,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start14 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood-onset Systemic Lupus ErythematousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part 1: establish Maximum tolerated dose Part 2: MTD to be given once weekly for 6 weeks
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cartesian Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089121
- Sponsor's protocol ID
- HELIOS-001
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No