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Clinical Trials in the USA / NCT07391605
Recruiting Phase 2

Descartes-08 in Autoantibody Myositis

NCT07391605 · tracked via the Priya Life Science USA tracker
Sponsor
Cartesian Therapeutics
Phase
Phase 2
Started
2026-04-28
Last updated
2026-08-17

Condition(s) studied

Antisynthetase Syndrome

Investigational drug(s) / intervention(s)

Descartes-08Placebo

Descartes-08: Autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA)

Placebo: Plasma-Lyte

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
University of California, Irvine Orange California Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
University of North Carolina Chapel Hill North Carolina Recruiting
National Neuromuscular Research Institute Austin Texas Recruiting

More Cartesian Therapeutics trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07391605 on ClinicalTrials.gov ↗ ← All trials in the USA