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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07391605

Enrollment

Registered

2026-02-06

Start date

2026-04-28

Completion date

2028-05-01

Last updated

2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antisynthetase Syndrome

Keywords

MYOSITIS, DESCARTES-08, MRNA CAR-T, TOTAL IMPROVEMENT SCORES, CDASI

Brief 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).

Interventions

DRUGDescartes-08

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

OTHERPlacebo

Plasma-Lyte

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Major improvement of 2016 ACR/EULAR Total Improvement score	24 weeks	Proportion of participants in the Descartes-08 group compared with placebo who achieve major improvement marked by ≥60 point improvement on the 2016 ACR/EULAR Total Improvement Score (TIS)

Countries

United States

Contacts

CONTACTCartesian Therapeutics

trials@cartesiantx.com617-231-8102

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026