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

RecruitingPhase 1/2

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)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Key Inclusion Criteria:

1. Adult ≥18 years old, able to provide informed consent
2. Clinical diagnosis of LMNA-related dilated cardiomyopathy (DCM) with LV systolic dysfunction
3. Pathogenic or likely pathogenic LMNA mutation confirmed by a CLIA-certified/CAP-accredited laboratory
4. NYHA Functional Class I, II, or III
5. LVEF \>25% and ≤45% by echocardiography
6. Implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator )CRT-D) implanted \>3 months prior to consent

Key Exclusion Criteria:

1. Any chronic medical condition that, in the Investigator's opinion, would compromise participant safety or compliance
2. Hospitalization as an inpatient for the following conditions within 3 months prior to signing the ICF: Heart failure, Persistent/refractory ventricular arrhythmia requiring external defibrillation, or multiple/recurrent cardioversion/defibrillation by ICD Indication for, or history of, LV assist device or cardiac transplantation due to end-stage cardiac dysfunction
3. Current or anticipated need for chronic IV inotropic therapy

About the study

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.

What is being tested

Sponsor: Nuevocor Pte. Ltd. · Participants: 21 · Started: Jun 16, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07606274

Locations in the U.S.

AlabamaUniversity of Alabama in Birmingham, Birmingham (Not yet recruiting)
CaliforniaCedars-Sinai Medical Center, Los Angeles
MassachusettsBrigham and Women's Hospital, Boston (Not yet recruiting)
MichiganUniversity of Michigan, Ann Arbor (Not yet recruiting)
MinnesotaMayo Clinic, Rochester
OhioThe Christ Hospital, Cincinnati (Not yet recruiting)
The Ohio State University, Columbus (Not yet recruiting)
TexasHouston Methodist Hospital, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.