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RECRUITING
NCT07606274
PHASE1/PHASE2

A Study With NVC-001 in Patients With LMNA-related Dilated Cardiomyopathy (SUNBEAM-LMNA)

Sponsor: Nuevocor Pte. Ltd.

View on ClinicalTrials.gov

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

Interventions

GENETIC

NVC-001 - Low Dose

Solution for intravenous infusion

GENETIC

NVC-001 - Intermediate Dose

Solution for intravenous infusion

GENETIC

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