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
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age ≥18 and ≤75
• A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria.
• Early active disease
• Evidence of significant skin, pulmonary, renal, or cardiac involvement
Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Florida
Mayo Clinic Florida
RECRUITING
Jacksonville
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
The University of Chicago Medical Center
RECRUITING
Chicago
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
North Carolina
Duke University
RECRUITING
Durham
New York
Columbia University Irving Medical Center
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Contact Information
Primary
Cabaletta Bio
clinicaltrials@cabalettabio.com
267 759 3100
Time Frame
Start Date: 2024-07-02
Estimated Completion Date: 2029-07
Participants
Target number of participants: 12
Treatments
Experimental: CABA-201
Severe Skin Cohort: Infusion of CABA-201 with preconditioning in subjects with SSc with severe skin involvement~Organ Cohort: Infusion of CABA-201 with preconditioning in subjects with SSc with organ involvement
Related Therapeutic Areas
Sponsors
Leads: Cabaletta Bio