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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Decartes-08 |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Brigham and Women's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
More Details
- Status
- Recruiting
- Sponsor
- Cartesian Therapeutics