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RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis
Sponsor: Cabaletta Bio
Summary
RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis
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 Systemic Sclerosis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2024-07-02
Completion Date
2029-07
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
CABA-201
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
Locations (10)
Yale University
New Haven, Connecticut, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Columbia University Irving Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Duke University
Durham, North Carolina, United States