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Clinical Trials/NCT07391605
NCT07391605
Not yet recruiting
Phase 2

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

Cartesian Therapeutics0 sites60 target enrollmentStarted: March 1, 2026Last updated:
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InterventionsDescartes-08Placebo

Overview

Phase
Phase 2
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
Major improvement of 2016 ACR/EULAR Total Improvement score
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

Decartes-08

Experimental

Intervention: Descartes-08 (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Major improvement of 2016 ACR/EULAR Total Improvement score

Time Frame: 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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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