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RecruitingPhase 2

Descartes-08 in Autoantibody Myositis

Cartesian Therapeutics · NCT07391605

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
60
US sites recruiting
4
Study start
April 28, 2026
Record last updated
August 17, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Descartes-08; Placebo

Conditions: Antisynthetase Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

Study contacts (from the official record)

  • Cartesian Therapeutics · 617-231-8102 · trials@cartesiantx.com