NCT07391605

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
24mo left

Started Apr 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026May 2028

First Submitted

Initial submission to the registry

January 29, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

April 28, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

January 29, 2026

Last Update Submit

April 22, 2026

Conditions

Antisynthetase Syndrome

Keywords

MYOSITISDESCARTES-08MRNA CAR-TTOTAL IMPROVEMENT SCORESCDASI

Outcome Measures

Primary Outcomes (1)

  • Major improvement of 2016 ACR/EULAR Total Improvement score

    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)

    24 weeks

Study Arms (2)

Decartes-08

EXPERIMENTAL
Drug: Descartes-08

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Descartes-08DRUG

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

Decartes-08
PlaceboOTHER

Plasma-Lyte

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

T13

Chapel Hill, North Carolina, 27599, United States

RECRUITING

T23

Austin, Texas, 78759, United States

RECRUITING

Related Publications (1)

  • Fedak, R.R., Ruggerie, R.N., Shan, Y. et al. BCMA-directed mRNA CAR-T cell therapy for myasthenia gravis: exploratory biomarker analysis of a placebo-controlled phase 2b trial. Nat Med (2026). https://doi.org/10.1038/s41591-025-04170-z

    BACKGROUND

Related Links

MeSH Terms

Conditions

Antisynthetase syndromeMyositis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Vera MD

CONTACT

6172318085trials@cartesiantx.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 6, 2026

Study Start

April 28, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

US(2)