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

Children's Hospital at Montefiore - Accepting Young Adult and Juvenile Patients

[...] Rheumatology classification criteria Diagnosis of DM, ASyS, or IMNM Evidence of active disease, despite prior or current tr [...]

ToIncidence evaluateof adverse events and laboratory abnormalities To characterize the pharmacodynamicsPharmacodynamics (PD) To characterize the pharmacokineticsPharmacokinetics (PK) ToChange evaluatein disease-related biomarkers of muscle inflammation ToChange evaluatein autoantibody-related biomarkers ToProportion evaluateof efficacyDM subjects achieving at least a moderate TIS without any immunomodulatory medications and no or low dose of steroids Mean change from baseline on the MMT-8 in subjects with DM and ASyS without any immunomodulatory medications and no or low dose of steroids Propo [...]

ToPhase evaluate1/2: Incidence and severity of adverse events reported(AEs) Phase by2b Sub-study 1: Proportion of DM & ASyS subjects achieving at least a moderate Total Improvement Score (TIS) without any immunomodulatory medications and no or low dose of steroids Phase 2b Sub-study 2: Proportion of subjects with IMNM achieving at least a minimal TIS without any immunomodulatory medications and no or low dose of steroids

Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile Patients University of Michigan - Accepting Young Adult and Juvenile Patients

[...] sm/American College of Rheumatology classification criteria Presence of serum myositis-specific antibodies or myositis-associated autoantibody Evidence of active disease, despite prior or current treatme [...]

Hospital for Special Surgery - Accepting Adult and Juvenile Patients Memorial Sloan Kettering Cancer Center - Accepting Adult and Juvenile Patients

[...] matology classification criteria Diagnosis of DM, ASyS, IMNM based on the presence of serum myositis-specific antibodies Evidence of active disease, despite prior or current treatm [...] ging (MRI), or electromyography Presence of muscle weakness Other protocol-defined criteria apply. Exclusion Criteria: Contraindication to leukapheresis ⇅ moved History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites ⇅ moved Active infection requiring medical intervention at screening ⇅ moved Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastr [...] [...]

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

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

Adult Cohorts Inclusion Criteria: Age ≥18 and ≤75 A clinical diagnosis of [...] cant lung or cardiac impairment Previous CAR T cell therapy Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant Juvenile Cohort Inclusion Criteria: Age ≥6 and ≤17 years at enrollment A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification crit [...] Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant

[...] ding dermatomyositis (DM), anti-synthetase syndrome (ASyS), and immune-mediated necrotizing myopathy (IMNM), and juvenile idiopathic inflammatory myopathy (JIIM), are thought to involve B cells that cause the body to att [...] apy, CABA-201, that can be given to patients with DM, ASyS, andIMNM, IMNMor JIIM who have active disease. A single dose of CABA-201 in combi [...]

University of California Irvine - Accepting Adult Patients Mayo Clinic Florida - Accepting Adult Patients Northwestern Memorial Hospital - Accepting Adult Patients The University of Chicago Medical Center - Accepting Adult and Juvenile Patients University of Kansas Medical Center - Accepting Adult Patients Mayo Clinic - Accepting Adult Patients Oregon Health & Science University - Accepting Adult Patients Vanderbilt University Medical Center - Accepting Adult Patients Houston Methodist Hospital - Accepting Adult Patients University of Texas MD Anderson Cancer Center - Accepting Adult Patients [...] [...]

[...] 201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

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

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