Recruiting
Phase 1
Phase 2

Descarte-08

Sponsor:

Cartesian Therapeutics

Code:

NCT07089121

Conditions

Childhood-onset Systemic Lupus Erythematous

ANCA-Associated Vasculitis (AAV)

Juvenile Myasthenia Gravis

Juvenile Dermatomyositis

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Descartes-08

Study Details

Brief 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

Conditions

Childhood-onset Systemic Lupus Erythematous

ANCA-Associated Vasculitis (AAV)

Juvenile Myasthenia Gravis

Juvenile Dermatomyositis

Study ID

NCT07089121

Start date

Jan 14, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Decartes-08 to establish Maximum tolerated dose

Intra-patient dose escalation arm with three dose levels over the course of six infusions of cell product.

experimental: Part 2: Decartes-08 infusions once weekly for 6 weeks

Descartes-08 infusions at the maximum tolerated dose level from Part 1.

Interventions

Descartes-08

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.

Primary outcome measure

  • Maximum tolerated dose in Part 1, type and frequency of treatment related SAE's in Part 2 [ Time Frame: Days 22 and 50 for Part1 , Days 22, 50 and Months 3,6,9 and 12 for part 2 ]
  • Maximum Dose Tolerated [ Time Frame: Days 2250 for Part 1, Days 11,50, month 3 for part 2 in addition to months, 4,6,9,12 ]

Central Contacts and Locations

Central contacts

Cartesian Clinical Trials

617-231-8102trials@cartesiantx.com

Locations

H01- Children's National Hospital

Recruiting

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

Contacts

Emily Miller

202-476-4130ejmiller@childrensnational.org

Principal Investigator:

Anant Vatsayan, MD

H03- Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Grace Goddard

314-454-6018pedshemonctrialreferral@wustl.edu

Principal Investigator:

Melissa Mavers, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Megan Quinlan-Waters

Megan.Quinlan-Waters@cchmc.org

Principal Investigator:

Hermine Brunner, MD

More Information

Sponsor

Cartesian Therapeutics

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cartesian Therapeutics on 2026-07-27.