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Descartes-08 for Autoantibody Myositis

This study is testing a treatment called Descartes-08 for people with autoantibody-mediated myositis, including Antisynthetase Syndrome (ASyS) and Dermatomyositis (DM). Descartes-08 involves using your own T-cells (a type of immune cell) that have been specially modified. The study will compare Descartes-08 to a placebo (an inactive substance like Plasma-Lyte). Researchers want to see if Descartes-08 is safe and effective in improving your condition. To join, you must be 18 or older and have a confirmed diagnosis of Dermatomyositis with a probability score of 55% or higher. The study aims to enroll 60 participants and will measure success by looking for a major improvement in your condition after 24 weeks. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled Phase 2 study involving about 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 24 weeks, suggesting follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07391605

Descartes-08 in Autoantibody Myositis

Recruiting
PHASE2Ages 18+InterventionalTreatment
Cartesian Therapeutics
~60 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Descartes-08Placebo

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major improvement of 2016 ACR/EULAR Total Improvement score
Measured over 24 weeks

Conditions

Antisynthetase Syndrome

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Where it's being run

4 sites across 4 states
California1
Massachusetts1
North Carolina1
Texas1

Who to contact

Cartesian Therapeutics
[email protected]
617-231-8102
Email the study team

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Eligibility criteria

Inclusion

Confirmed diagnosis of one of the following:
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

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.

What this trial measures

  • Major improvement of 2016 ACR/EULAR Total Improvement score24 weeks

    Proportion of participants in the Descartes-08 group compared with placebo who achieve major improvement marked by ≥60 point improvement on the 2016 ACR/EULAR Total Improvement Score (TIS)