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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

December 20, 2023

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2028

Conditions
Idiopathic Inflammatory MyopathyDermatomyositisAnti-Synthetase SyndromeImmune-Mediated Necrotizing MyopathyJuvenile DermatomyositisJuvenile PolymyositisJuvenile Idiopathic Inflammatory Myopathy (JIIM)Juvenile Myositis
Interventions
BIOLOGICAL

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

Trial Locations (25)

10021

RECRUITING

Hospital for Special Surgery - Accepting Adult and Juvenile Patients, New York

RECRUITING

Memorial Sloan Kettering Cancer Center - Accepting Adult and Juvenile Patients, New York

10467

NOT_YET_RECRUITING

Children's Hospital at Montefiore - Accepting Juvenile Patients, The Bronx

19104

RECRUITING

Children's Hospital of Philadelphia - Accepting Young Adult and Juvenile Patients, Philadelphia

20892

NOT_YET_RECRUITING

National Institutes of Health - Accepting Adult and Juvenile Patients, Bethesda

30032

RECRUITING

Emory University - Accepting Adult Patients, Atlanta

32224

RECRUITING

Mayo Clinic Florida - Accepting Adult Patients, Jacksonville

37232

RECRUITING

Vanderbilt University Medical Center - Accepting Adult Patients, Nashville

48105

RECRUITING

University of Michigan - Accepting Young Adult and Juvenile Patients, Ann Arbor

55902

RECRUITING

Mayo Clinic - Accepting Adult Patients, Rochester

60611

NOT_YET_RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile Patients, Chicago

RECRUITING

Northwestern Memorial Hospital - Accepting Adult Patients, Chicago

60637

RECRUITING

The University of Chicago Medical Center - Accepting Adult and Juvenile Patients, Chicago

66160

RECRUITING

University of Kansas Medical Center - Accepting Adult Patients, Kansas City

77030

RECRUITING

Houston Methodist Hospital - Accepting Adult Patients, Houston

RECRUITING

University of Texas MD Anderson Cancer Center - Accepting Adult Patients, Houston

80046

NOT_YET_RECRUITING

Children's Hospital Colorado - Accepting Juvenile Patients, Aurora

92868

RECRUITING

University of California Irvine - Accepting Adult Patients, Orange

94158

RECRUITING

University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile Patients, San Francisco

97239

RECRUITING

Oregon Health & Science University - Accepting Adult Patients, Portland

98105

NOT_YET_RECRUITING

Seattle Children's Research Institute - Accepting Juvenile Patients, Seattle

SE5 9RS

RECRUITING

Kings College Hospital NHS Foundation Trust - Accepting Adult Patients, London

WC1N 3BG

RECRUITING

University College London Hospitals NHS Foundation Trust - Accepting Adult Patients, London

M13 9WL

RECRUITING

Manchester Royal Infirmary - Accepting Adult Patients, Manchester

M6 8HD

RECRUITING

Salford Royal Hospital - Accepting Adult Patients, Salford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cabaletta Bio

INDUSTRY