Descartes-08 in Autoantibody Myositis

Cartesian Therapeutics

Status and phase

Begins enrollment this month

Phase 2

Conditions

Antisynthetase Syndrome

Treatments

Drug: Descartes-08

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07391605

RNAC-TRITON-08

Details and patient eligibility

About

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).

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.