Actively Recruiting
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
Led by Cabaletta Bio · Updated on 2026-05-14
74
Participants Needed
35
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial 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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Juveniles aged 6 to 17 years at enrollment
- Clinical diagnosis of idiopathic inflammatory myopathy based on 2017 classification criteria
- Diagnosis of dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy, or juvenile idiopathic inflammatory myopathy
- Evidence of active disease despite prior or current standard treatments, shown by elevated muscle enzymes, rash, or active disease on biopsy, MRI, or electromyography
- Presence of muscle weakness (adults)
- Other protocol-defined criteria apply
You will not qualify if you...
- Contraindication to leukapheresis
- History of severe allergic reaction to fludarabine, cyclophosphamide, or their metabolites
- Active infection needing medical treatment at screening
- Severe, progressive, or uncontrolled diseases affecting kidney, liver, blood, gastrointestinal tract, lungs, brain, heart, nervous system, or psychiatric health
- Significant lung or heart impairment
- Previous CAR T cell therapy
- Prior solid organ transplant or hematopoietic cell transplant
- Other protocol-defined criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
University of California Irvine - Accepting Adult Patients
Orange, California, United States, 92868
Actively Recruiting
2
University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile Patients
San Francisco, California, United States, 94158
Actively Recruiting
3
Children's Hospital Colorado - Accepting Juvenile Patients
Aurora, Colorado, United States, 80046
Actively Recruiting
4
Mayo Clinic Florida - Accepting Adult Patients
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Johns Hopkins All Children's Hospital - Accepting Juvenile Patients
St. Petersburg, Florida, United States, 33701
Actively Recruiting
6
Children's Healthcare of Atlanta - Accepting Juvenile Patients
Atlanta, Georgia, United States, 30029
Actively Recruiting
7
Emory University - Accepting Adult Patients
Atlanta, Georgia, United States, 30032
Actively Recruiting
8
Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile Patients
Chicago, Illinois, United States, 60611
Actively Recruiting
9
Northwestern Memorial Hospital - Accepting Adult Patients
Chicago, Illinois, United States, 60611
Actively Recruiting
10
The University of Chicago Medical Center - Accepting Adult and Juvenile Patients
Chicago, Illinois, United States, 60637
Actively Recruiting
11
University of Kansas Medical Center - Accepting Adult Patients
Kansas City, Kansas, United States, 66160
Actively Recruiting
12
National Institutes of Health - Accepting Adult and Juvenile Patients
Bethesda, Maryland, United States, 20892
Not Yet Recruiting
13
Boston Children's Hospital - Accepting Young Adults and Juvenile Patients
Boston, Massachusetts, United States, 02115
Actively Recruiting
14
University of Michigan - Accepting Young Adult and Juvenile Patients
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
15
Mayo Clinic - Accepting Adult Patients
Rochester, Minnesota, United States, 55902
Actively Recruiting
16
Hospital for Special Surgery - Accepting Adult and Juvenile Patients
New York, New York, United States, 10021
Actively Recruiting
17
Memorial Sloan Kettering Cancer Center - Accepting Adult and Juvenile Patients
New York, New York, United States, 10021
Actively Recruiting
18
Children's Hospital at Montefiore - Accepting Young Adult and Juvenile Patients
The Bronx, New York, United States, 10467
Actively Recruiting
19
University of North Carolina at Chapel Hill - Accepting Adult Patients
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
20
Duke University Medical Center - Accepting Young Adults and Juvenile Patients
Durham, North Carolina, United States, 27710
Actively Recruiting
21
Oregon Health & Science University - Accepting Adult Patients
Portland, Oregon, United States, 97239
Actively Recruiting
22
Children's Hospital of Philadelphia - Accepting Young Adult and Juvenile Patients
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
23
UPMC Children's Hospital of Pittsburgh - Accepting Juvenile Patients
Pittsburgh, Pennsylvania, United States, 15224
Not Yet Recruiting
24
UPMC Arthritis and Autoimmunity Center - Accepting Adult Patients
Pittsburgh, Pennsylvania, United States, 15261
Actively Recruiting
25
Vanderbilt University Medical Center - Accepting Adult Patients
Nashville, Tennessee, United States, 37232
Actively Recruiting
26
University of Texas Southwestern Medical Center - Accepting Juvenile Patients
Dallas, Texas, United States, 75390
Actively Recruiting
27
Houston Methodist Hospital - Accepting Adult Patients
Houston, Texas, United States, 77030
Actively Recruiting
28
University of Texas MD Anderson Cancer Center - Accepting Adult Patients
Houston, Texas, United States, 77030
Actively Recruiting
29
Primary Children's Hospital/University of Utah - Accepting Juvenile Patients
Salt Lake City, Utah, United States, 84113
Not Yet Recruiting
30
Seattle Children's Research Institute - Accepting Juvenile Patients
Seattle, Washington, United States, 98105
Actively Recruiting
31
Children's Wisconsin Pediatric Rheumatology -Accepting Young Adult and Juvenile Patients
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
32
Kings College Hospital NHS Foundation Trust - Accepting Adult Patients
London, United Kingdom, United Kingdom, SE5 9RS
Actively Recruiting
33
University College London Hospitals NHS Foundation Trust - Accepting Adult Patients
London, United Kingdom, United Kingdom, WC1N 3BG
Actively Recruiting
34
Manchester Royal Infirmary - Accepting Adult Patients
Manchester, United Kingdom, United Kingdom, M13 9WL
Actively Recruiting
35
Salford Royal Hospital - Accepting Adult Patients
Salford, United Kingdom, United Kingdom, M6 8HD
Actively Recruiting
Research Team
C
Cabaletta Bio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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