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
NCT ID: NCT06154252
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2023-12-20
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CABA-201
DM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with DM.
ASyS Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with ASyS.
IMNM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with IMNM.
JIIM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with JIIM.
CABA-201 following preconditioning with fludarabine and cyclophosphamide
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
Interventions
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CABA-201 following preconditioning with fludarabine and cyclophosphamide
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria
* Diagnosis of DM, ASyS, 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
* Presence of muscle weakness
Other protocol-defined criteria apply.
* 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 criteria
* Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated muscle enzymes, DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography
Other protocol-defined criteria apply.
Exclusion Criteria
* 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
* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures
* Significant lung or cardiac impairment
* Previous CAR T cell therapy
* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant
Other protocol-defined criteria apply.
Juvenile Cohort
* 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.
* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures
* Significant lung or cardiac impairment
* Previous CAR T cell therapy
* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant
Other protocol-defined criteria apply.
6 Years
75 Years
ALL
No
Sponsors
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Cabaletta Bio
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_CHAIR
Cabaletta Bio
Locations
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University of California Irvine - Accepting Adult Patients
Orange, California, United States
University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile Patients
San Francisco, California, United States
Children's Hospital Colorado - Accepting Juvenile Patients
Aurora, Colorado, United States
Mayo Clinic Florida - Accepting Adult Patients
Jacksonville, Florida, United States
Emory University - Accepting Adult Patients
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile Patients
Chicago, Illinois, United States
Northwestern Memorial Hospital - Accepting Adult Patients
Chicago, Illinois, United States
The University of Chicago Medical Center - Accepting Adult and Juvenile Patients
Chicago, Illinois, United States
University of Kansas Medical Center - Accepting Adult Patients
Kansas City, Kansas, United States
National Institutes of Health - Accepting Adult and Juvenile Patients
Bethesda, Maryland, United States
University of Michigan - Accepting Young Adult and Juvenile Patients
Ann Arbor, Michigan, United States
Mayo Clinic - Accepting Adult Patients
Rochester, Minnesota, United States
Hospital for Special Surgery - Accepting Adult and Juvenile Patients
New York, New York, United States
Memorial Sloan Kettering Cancer Center - Accepting Adult and Juvenile Patients
New York, New York, United States
Children's Hospital at Montefiore - Accepting Juvenile Patients
The Bronx, New York, United States
Oregon Health & Science University - Accepting Adult Patients
Portland, Oregon, United States
Children's Hospital of Philadelphia - Accepting Young Adult and Juvenile Patients
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center - Accepting Adult Patients
Nashville, Tennessee, United States
Houston Methodist Hospital - Accepting Adult Patients
Houston, Texas, United States
University of Texas MD Anderson Cancer Center - Accepting Adult Patients
Houston, Texas, United States
Seattle Children's Research Institute - Accepting Juvenile Patients
Seattle, Washington, United States
Kings College Hospital NHS Foundation Trust - Accepting Adult Patients
London, , United Kingdom
University College London Hospitals NHS Foundation Trust - Accepting Adult Patients
London, , United Kingdom
Manchester Royal Infirmary - Accepting Adult Patients
Manchester, , United Kingdom
Salford Royal Hospital - Accepting Adult Patients
Salford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Dr. Iazsmin Ventura, MD - Adult patient contact
Role: primary
Dr. Cuoghi Edens, MD, FAAP - Juvenile patient contact
Role: backup
Other Identifiers
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CAB-201-002
Identifier Type: -
Identifier Source: org_study_id
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