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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)
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
- NVC-001 - Low Dose (genetic)
- NVC-001 - Intermediate Dose (genetic)
- NVC-001 - High Dose (genetic)
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.
| Alabama | University of Alabama in Birmingham, Birmingham (Not yet recruiting) |
| California | Cedars-Sinai Medical Center, Los Angeles |
| Massachusetts | Brigham and Women's Hospital, Boston (Not yet recruiting) |
| Michigan | University of Michigan, Ann Arbor (Not yet recruiting) |
| Minnesota | Mayo Clinic, Rochester |
| Ohio | The Christ Hospital, Cincinnati (Not yet recruiting) The Ohio State University, Columbus (Not yet recruiting) |
| Texas | Houston 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.