RecruitingPhase 2NCT06092034

A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease

Gene Therapy for Danon Disease: A Phase 2 Study Evaluating the Efficacy and Safety of Intravenously Administered Adeno-Associated Virus Serotype 9 (rAAV9) Vector Containing the Human LAMP2 Isoform B Transgene (RP-A501; AAV9.LAMP2B) in Male Patients With Danon Disease


Sponsor

Rocket Pharmaceuticals Inc.

Enrollment

14 participants

Start Date

Sep 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm Phase 2 trial to evaluate the efficacy and safety of RP-A501, a recombinant adeno-associated virus serotype 9 (AAV9) containing the human lysosome-associated membrane protein 2 isoform B (LAMP2B) transgene, in male patients with Danon Disease.


Eligibility

Sex: MALEMin Age: 8 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying RP-A501 for people with danon disease. The study is currently recruiting participants at 6 locations. People eligible for this study include men aged 8 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

GENETICRP-A501

RP-A501 is a gene therapy product consisting of a rAAV9 capsid containing the human LAMP2B transgene which will be administered as a single IV infusion.


Locations(6)

University of California, San Diego

La Jolla, California, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

German Heart Center Munich

Munich, Germany

Meyer Childrens Hospital

Florence, Italy

Great Ormund Street Hospital & UCL Institute of Cardiovascular Science

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06092034


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