Descartes-08 in Autoantibody Myositis
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Antisynthetase Syndrome
In brief
This is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy, safety and tolerability of an autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA) in patients with autoantibody-mediated myositis, including antisynthetase syndrome (ASyS) and dermatomyositis (DM).
Key facts
- Study ID
- NCT07391605
- Run by
- Cartesian Therapeutics
- People needed
- 60
- Starts
- 2026-04-28
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- T13 — Chapel Hill, North Carolina, United States (enrolling)
- T23 — Austin, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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