Health Trials

RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

ConditionsIdiopathic Inflammatory MyopathyDermatomyositisAnti-Synthetase SyndromeImmune-Mediated Necrotizing MyopathyJuvenile DermatomyositisJuvenile PolymyositisJuvenile Idiopathic Inflammatory Myopathy (JIIM)Juvenile Myositis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age6-75
SponsorCabaletta Bio

About this trial

RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Eligibility criteria

Qualifiers

Age ≥18 and ≤75

A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria

Diagnosis of DM, ASyS, or IMNM

Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated creatine kinase (CK), DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography

Disqualifiers

Contraindication to leukapheresis

History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites

Active infection requiring medical intervention at screening

Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections

Trial design

Treatments tested in this trial

  • CABA-201 following preconditioning with fludarabine and cyclophosphamide

Treatment groups

74 Participants
are divided into 3 treatment groups

Locations

35
United Kingdom
Kings College Hospital NHS Foundation Trust - Accepting Adult PatientsSE5 9RS, London United Kingdom
University College London Hospitals NHS Foundation Trust - Accepting Adult PatientsWC1N 3BG, London United Kingdom
Manchester Royal Infirmary - Accepting Adult PatientsM13 9WL, Manchester United Kingdom
Salford Royal Hospital - Accepting Adult PatientsM6 8HD, Salford United Kingdom

Sponsors and collaborators

Cabaletta Bio

Lead sponsor

Source ClinicalTrials.gov