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New treatment option for Antisynthetase Syndrome
Official title Descartes-08 in Autoantibody Myositis
ClinicalTrials.gov ID: NCT07391605
What this study is testing
What is Descartes-08?
Descartes-08 is an investigational medicine, being studied as a potential treatment for antisynthetase syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmed diagnosis of one of the following: Dermatomyositis (DM): Probability score ≥55% on the 2017 EULAR/ACR (European Alliance of Associations of...
- 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).
You likely can't join 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States; Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.