RecruitingPhase 2NCT07391605

Descartes-08 in Autoantibody Myositis

A Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of Descartes-08 in Patients With Dermatomyositis and Antisynthetase Syndrome

Sponsor

Cartesian Therapeutics

Enrollment

60 participants

Start Date

Apr 28, 2026

Study Type

INTERVENTIONAL

Conditions

Antisynthetase Syndrome

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria11

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.