RecruitingPhase 1Phase 2NCT07606274

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

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)

Sponsor

Nuevocor Pte. Ltd.

Enrollment

21 participants

Start Date

Jun 16, 2026

Study Type

INTERVENTIONAL

Conditions

LMNA-Related Dilated Cardiomyopathy

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying NVC-001 - High Dose, NVC-001 - Intermediate Dose, and others for people with lmna-related dilated cardiomyopathy. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

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

GENETICNVC-001 - Low Dose

Solution for intravenous infusion

GENETICNVC-001 - Intermediate Dose

Solution for intravenous infusion

GENETICNVC-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

View Full Details on ClinicalTrials.gov

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NCT07606274