Descartes-08 in Autoantibody Myositis

Purpose

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).

Condition

  • Antisynthetase Syndrome

Eligibility

Eligible Ages
Over 18 Years
Eligible 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. - Active or uncontrolled infections: HBV, HCV, HIV, tuberculosis, or recurrent/severe infections.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Decartes-08
  • Drug: Descartes-08
    Autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA)
Placebo Comparator
Placebo
  • Other: Placebo
    Plasma-Lyte

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115

More Details

Status
Recruiting
Sponsor
Cartesian Therapeutics

Study Contact

Cartesian Therapeutics
617-231-8102
trials@cartesiantx.com