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
Cabaletta Bio · NCT06154252
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 6–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2, Phase 3
- Target enrollment
- 74
- US sites recruiting
- 30
- Study start
- December 20, 2023
- Record last updated
- October 15, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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
Being studied: CABA-201 following preconditioning with fludarabine and cyclophosphamide
Conditions: Idiopathic Inflammatory Myopathy; Dermatomyositis; Anti-Synthetase Syndrome; Immune-Mediated Necrotizing Myopathy; Juvenile Dermatomyositis; Juvenile Polymyositis; Juvenile Idiopathic Inflammatory Myopathy (JIIM); Juvenile Myositis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Adult Cohorts
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
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 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
- 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.
Recruiting US locations
University of California Irvine - Accepting Adult Patients
Orange, CA 92868
Site contact: Alpha Clinic · 949-824-3990 · alphaclinic@uci.edu
University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile Patients
San Francisco, CA 94158
Site contact: Zilan Zheng · 415-353-1301 · Zilan.Zheng@ucsf.edu
Children's Hospital Colorado - Accepting Juvenile Patients
Aurora, CO 80046
Site contact: Callie Strini - Primary Clinical Research Coordinator · 720-777-9845 · callie.strini@childrenscolorado.org
Mayo Clinic Florida - Accepting Adult Patients
Jacksonville, FL 32224
Site contact: Gabrielle Pariseau · 904-953-5549 · pariseau.gabrielle@mayo.edu
Johns Hopkins All Children's Hospital - Accepting Juvenile Patients
St. Petersburg, FL 33701
Site contact: Laura Escobar · 727-767-2946 · llabarr2@jh.edu
Children's Healthcare of Atlanta - Accepting Juvenile Patients
Atlanta, GA 30029
Site contact: Judson Russell · 404-785-7263 · Judson.russell@choa.org
Emory University - Accepting Adult Patients
Atlanta, GA 30032
Site contact: John Varghese · john.varghese@emory.edu
Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile Patients
Chicago, IL 60611
Site contact: Tyler Sorensen · 312-277-6828 · tsorensen@luriechildrens.org
Northwestern Memorial Hospital - Accepting Adult Patients
Chicago, IL 60611
Site contact: Kaitlin King · 312-695-0990 · autoimmunesct@nm.org
The University of Chicago Medical Center - Accepting Adult and Juvenile Patients
Chicago, IL 60637
Site contact: Dr. Iazsmin Ventura, MD - Adult patient contact · 773-702-6619 · iventura@uchicago.edu; Dequana.jones@bsd.uchicago.edu
University of Kansas Medical Center - Accepting Adult Patients
Kansas City, KS 66160
Site contact: Samantha Colgan · 913-945-9938 · scolgan@kumc.edu
National Institutes of Health - Accepting Adult and Juvenile Patients
Bethesda, MD 20892
Site contact: Julie Thompson · 301-480-3191 · Julie.thompson@nih.gov
Boston Children's Hospital - Accepting Young Adults and Juvenile Patients
Boston, MA 02115
Site contact: Kyle McBrearty · 617-355-2780 · kyle.mcbrearty@childrens.harvard.edu
University of Michigan - Accepting Young Adult and Juvenile Patients
Ann Arbor, MI 48105
Site contact: Abigail Whalen · 734-615-4466 · abigaiwh@med.umich.edu
Mayo Clinic - Accepting Adult Patients
Rochester, MN 55902
Site contact: Bridget Neja · 507-266-9150 · neja.bridget@mayo.edu
Hospital for Special Surgery - Accepting Adult and Juvenile Patients
New York, NY 10021
Site contact: Janvi Bhatia · 212-774-2123 · bhatiaj@hss.edu
Memorial Sloan Kettering Cancer Center - Accepting Adult and Juvenile Patients
New York, NY 10021
Site contact: Atifah Osrat · 646-608-2091 · osrata1@mskcc.org
Children's Hospital at Montefiore - Accepting Young Adult and Juvenile Patients
The Bronx, NY 10467
Site contact: Emily Gillies · 718-696-2402 · egillies@montefiore.org
University of North Carolina at Chapel Hill - Accepting Adult Patients
Chapel Hill, NC 27599
Site contact: Leah Luizza · leah.luizza@med.unc.edu
Duke University Medical Center - Accepting Young Adults and Juvenile Patients
Durham, NC 27710
Site contact: Lynn Rodgers, MS · 919-668-2953 · Lynn.rodgers@duke.edu
Oregon Health & Science University - Accepting Adult Patients
Portland, OR 97239
Site contact: Katie Lewis · 503-908-9724 · lewiskat@ohsu.edu
Children's Hospital of Philadelphia - Accepting Young Adult and Juvenile Patients
Philadelphia, PA 19104
Site contact: CARTintake@chop.edu · CARTintake@chop.edu
UPMC Children's Hospital of Pittsburgh - Accepting Juvenile Patients
Pittsburgh, PA 15224
Site contact: Vibha Chauhan, PhD · 412-692-7924 · Vibha.chauhan@chp.edu
UPMC Arthritis and Autoimmunity Center - Accepting Adult Patients
Pittsburgh, PA 15261
Site contact: Carol Oriss · orissca@upmc.edu
Vanderbilt University Medical Center - Accepting Adult Patients
Nashville, TN 37232
Site contact: Tofi Soneye · 817-883-4730 · tofi.soneye@vumc.org
University of Texas Southwestern Medical Center - Accepting Juvenile Patients
Dallas, TX 75390
Site contact: Dr. Samuel John · dtpteam@childrens.com
Houston Methodist Hospital - Accepting Adult Patients
Houston, TX 77030
Site contact: Amelia A. Nounes, MSN, RN, CCRP · 346-356-3639 · aanounes@houstonmethodist.org
University of Texas MD Anderson Cancer Center - Accepting Adult Patients
Houston, TX 77030
Site contact: Christina Amos Briggs, BSN, RN · 713-563-5076 · cbamos@mdanderson.org
Primary Children's Hospital/University of Utah - Accepting Juvenile Patients
Salt Lake City, UT 84113
Site contact: Morgan Badgley - Research Coordinator · 801-662-4812 · morgan.badgley@hsc.utah.edu
Seattle Children's Research Institute - Accepting Juvenile Patients
Seattle, WA 98105
Site contact: Dr. Susan Shenoi, MD, MS · 206-987-2193 · susan.shenoi@SeattleChildrens.org
Study contacts (from the official record)
- Cabaletta Bio · 267-759-3100 · clinicaltrials@cabalettabio.com