Descartes-08 in Autoantibody Myositis
ConditionAntisynthetase Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCartesian Therapeutics
About this trial
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).
Eligibility criteria
Qualifiers
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).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Descartes-08
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov