AB-1002 in Patients With Class III Heart Failure

Summary

This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of AB-1002 in patients with NYHA Class III heart failure. Patients with non-ischemic cardiomyopathy will be enrolled until up to 17 subjects have received infusions of investigational product. All patients will be followed until 12 months post treatment intervention, and then undergo long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).

Timeline

Start

2019-11-20

Primary completion

2024-08-20

Completion

2026-09-30

Publications

• Henry TD, Chung ES, Alvisi M, Sethna F, Murray DR, Traverse JH, Roessig L, Roberts L, Reddy S, Chen Y, Ozkan TG, Webb S, Mittal M, Ervin L, Sadek H, Mikhail S, Haghighi K, Jiang C, Samulski RJ, Kranias EG, Tretiakova AP, Hajjar RJ. Cardiotropic AAV gene therapy for heart failure: a phase 1 trial. Nat Med. 2025 Nov;31(11):3845-3852. doi: 10.1038/s41591-025-04011-z. Epub 2025 Oct 21.

Drugs

Indications