NCT07391605PHASE2Recruiting
Descartes-08 in Autoantibody Myositis
Cartesian Therapeutics
Start Date
4/28/2026
Completion Date
5/1/2028
Summary
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).
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DRUG
Descartes-08
OTHER
Placebo
Conditions
Antisynthetase Syndrome
Locations
University of California, Irvine
Orange, California 92868
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
University of North Carolina
Chapel Hill, North Carolina 27599
United States
National Neuromuscular Research Institute
Austin, Texas 78759
United States