Descartes-08 for autoantibody myositis (antisynthetase syndrome and dermatomyositis)
Official title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of Descartes-08 in Patients With Dermatomyositis and Antisynthetase Syndrome
Run by Cartesian Therapeutics · NCT07391605 · Data updated 2026-11-12
This trial will test whether Descartes-08, an mRNA CAR-T therapy targeting BCMA, can help adults with autoantibody-driven myositis such as antisynthetase syndrome or dermatomyositis who have not responded to standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Cartesian Therapeutics Industry-sponsored |
| Drugs / interventions | chimeric antigen receptor |
| Locations | 4 sites (Orange, California and 3 other locations) |
| Status | Recruiting |
| Started | April 28, 2026 |
| Main results expected | November 2027 |
| Study ends | May 2028 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT07391605 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with dermatomyositis or antisynthetase syndrome who have muscle or skin involvement, have failed or cannot tolerate standard therapies, are on stable immunosuppression, and meet organ function and safety criteria for leukapheresis and cell therapy.
✕Probably not a fit
Patients with isolated interstitial lung disease without muscle or skin involvement, those with severe irreversible muscle damage or advanced weakness (for example, wheelchair-bound), or those with inadequate hematologic, hepatic, renal, or pulmonary function are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind, placebo-controlled phase 2 trial gives participants an autologous mRNA CAR-T product (Descartes-08) engineered to target B-cell maturation antigen (BCMA) to deplete autoantibody-producing B cells. Adults with dermatomyositis or antisynthetase syndrome with muscle and/or skin involvement who are refractory or intolerant to standard therapy and on stable immunosuppression are randomized to receive Descartes-08 or placebo with follow-up for efficacy and safety. Primary measures include clinical improvement scores such as Total Improvement Score and skin disease activity by CDASI, along with safety and tolerability assessments. Procedures include leukapheresis to collect autologous T cells, infusion of the mRNA CAR-T product, and serial clinic visits at sites in North Carolina and Texas.
Why it matters
Potential benefit: If successful, the therapy could reduce autoantibody-producing B cells and improve muscle and skin symptoms in patients who have not responded to existing treatments.
How similar studies have gone: BCMA-targeted CAR-T therapies have been highly effective in B-cell malignancies and early case reports and small studies suggest B-cell targeting can help some autoimmune conditions, but applying mRNA CAR-T to myositis is a novel and still experimental approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of one of the following: Dermatomyositis (DM): Probability score ≥55% on the 2017 EULAR/ACR (European Alliance of Associations of Rheumatology/ American College of Rheumatology) criteria for classification of dermatomyositis (corresponding to diagnosis of 'probable or definite' DM). OR Antisynthetase Syndrome (ASyS): Diagnosis based on ACR/EULAR Classification Criteria (1)." * Participants must have dermatomyositis or antisynthetase syndrome with muscle and/or skin involvement. * Refractory or intolerance to standard therapy. * Stable background immunosuppressive therapy for ≥8 weeks. * Adequate hematologic, renal, hepatic, and pulmonary function (SpO₂ ≥92% on room air). * Informed consent, compliance with visits, contraception, and vaccinations required. Exclusion Criteria: * Isolated interstitial lung disease (ILD) without muscle or skin involvement * Severe irreversible muscle damage or advanced weakness (e.g., wheelchair-bound). * Interstitial lung disease (ILD) requiring oxygen, severe pulmonary impairment (FVC ≤45%, DLCO ≤40%), or pulmonary hypertension. * Other inflammatory myopathies (PM, IMNM, IBM, cancer- or drug-induced myositis, overlap myositis except Sjögren's). * Other severe neuromuscular, cardiac, pulmonary, or systemic autoimmune diseases requiring immunosuppression. * Significant uncontrolled chronic illnesses or psychiatric conditions interfering with participation. * Pregnancy or lactation. * Recent use of prohibited immunosuppressants/biologics or investigational agents (per washout periods). * Live vaccination within 4 weeks. * History of primary immunodeficiency, organ or bone marrow transplant. * Active or uncontrolled infections: HBV, HCV, HIV, tuberculosis, or recurrent/severe infections.
Where it's running
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University of California, Irvine
Orange, California, United States Recruiting -
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
University of North Carolina
Chapel Hill, North Carolina, United States Recruiting -
National Neuromuscular Research Institute
Austin, Texas, United States Recruiting
Study contacts
- Study coordinator: Cartesian Therapeutics
- Email: trials@cartesiantx.com
- Phone: 617-231-8102
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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JAK inhibitors versus calcineurin inhibitors as initial therapy for antisynthetase syndrome–associated ILD
This trial tests whether a JAK inhibitor or a calcineurin inhibitor, given with steroids, works better as the first treatment for antisynthetase syndrome–related interstitial lung disease in adults who haven’t been treated yet.
-
Using CD19 CAR NK cells to treat refractory antisynthetase antibody syndrome and rheumatoid arthritis
This study tests if a new treatment using special immune cells can help people with tough cases of antisynthetase antibody syndrome and rheumatoid arthritis feel better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.