Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07391605

Descartes-08 in Autoantibody Myositis

Led by Cartesian Therapeutics · Updated on 2026-04-23

60

Participants Needed

2

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial 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).

CONDITIONS

Official Title

Descartes-08 in Autoantibody Myositis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of dermatomyositis with a probability score 65% on the 2017 EULAR/ACR criteria or confirmed antisynthetase syndrome based on ACR/EULAR classification criteria
  • Dermatomyositis or antisynthetase syndrome with muscle and/or skin involvement
  • Refractory or intolerant to standard therapy
  • Stable background immunosuppressive therapy for at least 8 weeks
  • Adequate hematologic, renal, hepatic, and pulmonary function with oxygen saturation (SpO2) 6592% on room air
  • Ability to provide informed consent, comply with study visits, use contraception, and receive vaccinations
Not Eligible

You will not qualify if you...

  • Isolated interstitial lung disease without muscle or skin involvement
  • Severe irreversible muscle damage or advanced weakness such as being wheelchair-bound
  • Interstitial lung disease requiring oxygen, severe pulmonary impairment (FVC 6445%, DLCO 6440%), or pulmonary hypertension
  • Other inflammatory myopathies including polymyositis, immune-mediated necrotizing myopathy, inclusion body myositis, cancer- or drug-induced myositis, or overlap myositis except Sj�f6gren's syndrome
  • 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 according to washout periods
  • Live vaccination within 4 weeks prior to the study
  • History of primary immunodeficiency, organ or bone marrow transplant
  • Active or uncontrolled infections including HBV, HCV, HIV, tuberculosis, or recurrent/severe infections

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

T13

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

2

T23

Austin, Texas, United States, 78759

Actively Recruiting

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Research Team

V

Vera MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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