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Virus Therapy

LX2020 for Arrhythmogenic Cardiomyopathy

Phase 1 & 2

Recruiting

Research Sponsored by Lexeo Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

"This trial is testing a new drug called LX2020 in adult patients with a heart condition called PKP2-ACM. The trial will determine the safety and tolerability of the drug through increasing

Who is the study for?

This trial is for adults with a specific heart condition called Arrhythmogenic Cardiomyopathy (ACM) due to a PKP2 gene variant. Participants must meet certain diagnostic criteria, have frequent irregular heartbeats known as PVCs, and have had an ICD (a device that can prevent sudden death from cardiac arrest) implanted for at least 12 weeks. They should also have a left ventricular ejection fraction of 50% or higher.Check my eligibility

What is being tested?

The trial is testing LX2020, which is a new gene therapy given through the veins. It's in early stages of testing (Phase 1/2), where researchers are trying to find out how safe it is and what doses are tolerable when given to humans for the first time.See study design

What are the potential side effects?

Since this is an early-phase trial for LX2020, exact side effects aren't fully known yet. However, potential risks may include reactions at the infusion site, immune responses to the therapy, or other unforeseen complications related to gene therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of subjects who experienced at least 1 treatment emergent adverse event (TEAE) and/or 1 treatment emergent serious adverse event (TESAE).

Other outcome measures

Selected Exploratory

Trial Design

1Treatment groups

Experimental Treatment

Group I: LX2020Experimental Treatment1 Intervention

Single ascending dose of LX2020, with a starting dose of 2.0 x10^13 gc/kg, in multiple cohorts

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lexeo TherapeuticsLead Sponsor

3 Previous Clinical Trials

39 Total Patients Enrolled

LEXEO Clinical TrialsStudy DirectorLexeo Therapeutics

1 Previous Clinical Trials

9 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an inclusion of individuals aged 85 and above in this medical research study?

"As specified in the eligibility requirements, individuals aged 18 and above but below 65 are eligible for enrollment into this clinical trial."

Answered by AI

Is the enrollment for participants currently open in this clinical trial?

"According to details on clinicaltrials.gov, this research study is currently seeking eligible participants. The trial was initially published on February 29th, 2024, and last revised on March 8th, 2024."

Answered by AI

What is the current participation count in this clinical trial?

"Affirmative. Details on clinicaltrials.gov confirm the ongoing patient recruitment for this trial, initially posted on February 29th, 2024, and most recently revised on March 8th of the same year. The trial aims to enroll a total of 10 patients at one designated site."

Answered by AI

For which individuals is participation in this research study deemed appropriate?

"This clinical study aims to enroll 10 individuals aged between 18 and 65 with arrhythmogenic cardiomyopathy. Specifically, eligible participants must fulfill the subsequent conditions: Being adults diagnosed with ACM according to the revised Task Force Criteria (TFC) of 2010, Having genetic test results confirming a harmful or potentially harmful variant in PKP2 gene, Presenting frequent premature ventricular complexes (PVCs), Receiving an implantable cardioverter-defibrillator (ICD) at least 12 weeks before giving consent, Maintaining a left ventricular ejection fraction of equal to or more than 50%."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gene Therapy for ACM Due to a PKP2 Pathogenic Variant

2024. "Gene Therapy for ACM Due to a PKP2 Pathogenic Variant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06109181.

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