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A Study With NVC-001 in Patients With LMNA-related Dilated Cardiomyopathy (SUNBEAM-LMNA)
Sponsor: Nuevocor Pte. Ltd.
Summary
This study is designed to evaluate the safety and tolerability of NVC-001 in adults with LMNA-related dilated cardiomyopathy (LMNA-DCM). The study will also assess exploratory measures of efficacy.
Official title: A Phase 1/2, First-in-Human, Open-Label, Multicenter, Single-Dose Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of NVC-001, a Novel Adeno-Associated Virus (Serotype 9) Vector Expressing a Dominant Negative SUN1 Transgene, in Patients With LMNA-Related Dilated Cardiomyopathy (SUNBEAM-LMNA)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2026-06-16
Completion Date
2030-03
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
NVC-001 - Low Dose
Solution for intravenous infusion
NVC-001 - Intermediate Dose
Solution for intravenous infusion
NVC-001 - High Dose
Solution for intravenous infusion
Locations (6)
University of Alabama in Birmingham
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
The Christ Hospital
Cincinnati, Ohio, United States
Houston Methodist Hospital
Houston, Texas, United States