RecruitingPhase 1Phase 2NCT06328777

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

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

Sponsor

Cabaletta Bio

Enrollment

12 participants

Start Date

Jul 2, 2024

Study Type

INTERVENTIONAL

Conditions

Scleroderma Systemic Sclerosis

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CABA-201 for people with scleroderma and systemic sclerosis. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCABA-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

View Full Details on ClinicalTrials.gov

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NCT06328777

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