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RECRUITING
NCT06328777
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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