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

ClinicalTrials.gov ID: NCT06154252

Public ClinicalTrials.gov record NCT06154252. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 7, 2026, 9:36 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID: NCT06154252
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Cabaletta Bio; Industry
Enrollment: 74 participants

Conditions and interventions

Conditions

Interventions

CABA-201 following preconditioning with fludarabine and cyclophosphamide Biological

Biological

Eligibility (public fields only)

Age range: 6 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 19, 2023
Primary completion: Jun 30, 2028
Completion: Jun 30, 2028
Last update posted: Apr 28, 2026

2023 – 2028

United States locations

U.S. sites: 31
U.S. states: 19
U.S. cities: 25

Facility	City	State	ZIP	Site status
University of California Irvine - Accepting Adult Patients	Orange	California	92868	Recruiting
University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile Patients	San Francisco	California	94158	Recruiting
Children's Hospital Colorado - Accepting Juvenile Patients	Aurora	Colorado	80046	Recruiting
Mayo Clinic Florida - Accepting Adult Patients	Jacksonville	Florida	32224	Recruiting
Johns Hopkins All Children's Hospital - Accepting Juvenile Patients	St. Petersburg	Florida	33701	Recruiting
Children's Healthcare of Atlanta - Accepting Juvenile Patients	Atlanta	Georgia	30029	Recruiting
Emory University - Accepting Adult Patients	Atlanta	Georgia	30032	Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile Patients	Chicago	Illinois	60611	Recruiting
Northwestern Memorial Hospital - Accepting Adult Patients	Chicago	Illinois	60611	Recruiting
The University of Chicago Medical Center - Accepting Adult and Juvenile Patients	Chicago	Illinois	60637	Recruiting
University of Kansas Medical Center - Accepting Adult Patients	Kansas City	Kansas	66160	Recruiting
National Institutes of Health - Accepting Adult and Juvenile Patients	Bethesda	Maryland	20892	Not yet recruiting
Boston Children's Hospital - Accepting Young Adults and Juvenile Patients	Boston	Massachusetts	02115	Recruiting
University of Michigan - Accepting Young Adult and Juvenile Patients	Ann Arbor	Michigan	48105	Recruiting
Mayo Clinic - Accepting Adult Patients	Rochester	Minnesota	55902	Recruiting
Hospital for Special Surgery - Accepting Adult and Juvenile Patients	New York	New York	10021	Recruiting
Memorial Sloan Kettering Cancer Center - Accepting Adult and Juvenile Patients	New York	New York	10021	Recruiting
Children's Hospital at Montefiore - Accepting Young Adult and Juvenile Patients	The Bronx	New York	10467	Recruiting
University of North Carolina at Chapel Hill - Accepting Adult Patients	Chapel Hill	North Carolina	27599	Recruiting
Duke University Medical Center - Accepting Young Adults and Juvenile Patients	Durham	North Carolina	27710	Recruiting
Oregon Health & Science University - Accepting Adult Patients	Portland	Oregon	97239	Recruiting
Children's Hospital of Philadelphia - Accepting Young Adult and Juvenile Patients	Philadelphia	Pennsylvania	19104	Recruiting
UPMC Children's Hospital of Pittsburgh - Accepting Juvenile Patients	Pittsburgh	Pennsylvania	15224	Not yet recruiting
UPMC Arthritis and Autoimmunity Center - Accepting Adult Patients	Pittsburgh	Pennsylvania	15261	Not yet recruiting
Vanderbilt University Medical Center - Accepting Adult Patients	Nashville	Tennessee	37232	Recruiting
University of Texas Southwestern Medical Center - Accepting Juvenile Patients	Dallas	Texas	75390	Recruiting
Houston Methodist Hospital - Accepting Adult Patients	Houston	Texas	77030	Recruiting
University of Texas MD Anderson Cancer Center - Accepting Adult Patients	Houston	Texas	77030	Recruiting
Primary Children's Hospital/University of Utah - Accepting Juvenile Patients	Salt Lake City	Utah	84113	Not yet recruiting
Seattle Children's Research Institute - Accepting Juvenile Patients	Seattle	Washington	98105	Recruiting
Children's Wisconsin Pediatric Rheumatology -Accepting Young Adult and Juvenile Patients	Milwaukee	Wisconsin	53226	Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06154252, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 28, 2026 · Synced May 7, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06154252 live on ClinicalTrials.gov.

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