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Taking people in United StatesPhase 2/3

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

Key facts

Where
Ann Arbor, Atlanta, Aurora, Bethesda, Boston, Chapel Hill, Chicago, Dallas, Durham, Houston, Jacksonville, Kansas City, Milwaukee, Nashville, New York, Orange, Philadelphia, Pittsburgh, Portland, Rochester, Salt Lake City, San Francisco, Seattle, St. Petersburg, and The Bronx, United StatesSee the 31 sites
Phase
Phase 2/3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 75 years old?

Source: NCT06154252, who can take part

Where in United States

  • University of Michigan - Accepting Young Adult and Juvenile PatientsAnn Arbor, United StatesContact: Abigail WhalenTaking people
  • Children's Healthcare of Atlanta - Accepting Juvenile PatientsAtlanta, United StatesContact: Judson RussellTaking people
  • Emory University - Accepting Adult PatientsAtlanta, United StatesContact: John VargheseTaking people
  • Children's Hospital Colorado - Accepting Juvenile PatientsAurora, United StatesTaking people
  • National Institutes of Health - Accepting Adult and Juvenile PatientsBethesda, United StatesContact: Julie ThompsonTaking people
  • Boston Children's Hospital - Accepting Young Adults and Juvenile PatientsBoston, United StatesContact: Kyle McBreartyTaking people
  • University of North Carolina at Chapel Hill - Accepting Adult PatientsChapel Hill, United StatesContact: Leah LuizzaTaking people
  • Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile PatientsChicago, United StatesContact: Tyler SorensenTaking people
  • Northwestern Memorial Hospital - Accepting Adult PatientsChicago, United StatesContact: Kaitlin KingTaking people
  • The University of Chicago Medical Center - Accepting Adult and Juvenile PatientsChicago, United StatesContact: Dr. Iazsmin Ventura, MD (principal investigator)Taking people
  • University of Texas Southwestern Medical Center - Accepting Juvenile PatientsDallas, United StatesContact: Dr. Samuel JohnTaking people
  • Duke University Medical Center - Accepting Young Adults and Juvenile PatientsDurham, United StatesContact: Lynn Rodgers, MSTaking people
  • Houston Methodist Hospital - Accepting Adult PatientsHouston, United StatesContact: Amelia A. Nounes, MSN, RN, CCRPTaking people
  • University of Texas MD Anderson Cancer Center - Accepting Adult PatientsHouston, United StatesContact: Christina Amos Briggs, BSN, RNTaking people
  • Mayo Clinic Florida - Accepting Adult PatientsJacksonville, United StatesContact: Gabrielle PariseauTaking people
  • University of Kansas Medical Center - Accepting Adult PatientsKansas City, United StatesContact: Samantha ColganTaking people
  • Children's Wisconsin Pediatric Rheumatology -Accepting Young Adult and Juvenile PatientsMilwaukee, United StatesContact: Erin Hammelev - Research CoordinatorNot yet recruiting
  • Vanderbilt University Medical Center - Accepting Adult PatientsNashville, United StatesContact: Tofi SoneyeTaking people
  • Hospital for Special Surgery - Accepting Adult and Juvenile PatientsNew York, United StatesContact: Janvi BhatiaTaking people
  • Memorial Sloan Kettering Cancer Center - Accepting Adult and Juvenile PatientsNew York, United StatesContact: Atifah OsratTaking people
  • University of California Irvine - Accepting Adult PatientsOrange, United StatesContact: Alpha ClinicTaking people
  • Children's Hospital of Philadelphia - Accepting Young Adult and Juvenile PatientsPhiladelphia, United StatesContact: Dr. Caitlin Elgarten, MD, MSCE (principal investigator)Taking people
  • UPMC Arthritis and Autoimmunity Center - Accepting Adult PatientsPittsburgh, United StatesContact: Carol OrissTaking people
  • UPMC Children's Hospital of Pittsburgh - Accepting Juvenile PatientsPittsburgh, United StatesContact: Vibha Chauhan, PhDTaking people
  • Oregon Health & Science University - Accepting Adult PatientsPortland, United StatesContact: Katie LewisTaking people
  • Mayo Clinic - Accepting Adult PatientsRochester, United StatesContact: Bridget NejaTaking people
  • Primary Children's Hospital/University of Utah - Accepting Juvenile PatientsSalt Lake City, United StatesContact: Morgan Badgley - Research CoordinatorTaking people
  • University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile PatientsSan Francisco, United StatesContact: Zilan ZhengTaking people
  • Seattle Children's Research Institute - Accepting Juvenile PatientsSeattle, United StatesContact: Dr. Susan Shenoi, MD, MSTaking people
  • Johns Hopkins All Children's Hospital - Accepting Juvenile PatientsSt. Petersburg, United StatesContact: Laura EscobarTaking people
  • Children's Hospital at Montefiore - Accepting Young Adult and Juvenile PatientsThe Bronx, United StatesContact: Emily GilliesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Cabaletta Bio
Trial code
NCT06154252EU 2025-521145-24-01
Record updated
15 October 2026
Original description
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 MyopathyRead full original descriptionShow less

A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

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

Inclusion: 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; 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: 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; Previous CAR T cell therapy; Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant; Other protocol-defined criteria apply; Juvenile Cohort; 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; Previous CAR T cell therapy; Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant; Other protocol-defined criteria apply; 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; Significant lung or cardiac impairment; 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; Significant lung or cardiac impairment; Contraindication to leukapheresis; Contraindication to leukapheresis.

Adult Cohorts.

ClinicalTrials.gov NCT06154252 · EU CTIS 2025-521145-24-01