Status:
ACTIVE_NOT_RECRUITING
Gene Therapy for ACM Due to a PKP2 Pathogenic Variant
Lead Sponsor:
Lexeo Therapeutics
Conditions:
Arrhythmogenic Cardiomyopathy
PKP2-ACM
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase 1/2, first-in-human, open-label, intravenous, dose-escalating, multicenter trial that is designed to assess the safety and tolerability of LX2020 in adult patients with PKP2-ACM
Eligibility Criteria
Inclusion
- Selected
- Adults with a clinical diagnosis of ACM meeting the 2010 revised Task Force Criteria (TFC)
- Genetic testing documenting a pathogenic or likely pathogenic variant in PKP2
- Frequent premature ventricular complexes (PVCs)
- Implantable cardioverter-defibrillator (ICD) implantation ≥ 12 weeks prior to the pre-screening MRI
- Left ventricular ejection fraction ≥ 40%
- Selected
Exclusion
- Evidence of variant(s) in addition to PKP2 that meets the standard criteria to be considered pathogenic or likely pathogenic for ACM
- Other cardiac abnormalities as specified in the protocol
- New York Heart Association Functional Class IV at the time of consent
- History of prior gene transfer therapy
Key Trial Info
Start Date :
February 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06109181
Start Date
February 29 2024
End Date
March 1 2027
Last Update
November 12 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Stanford, California, United States, 94305
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
University of Rochester
Rochester, New York, United States, 14642