Study Assessing Left Ventricular Administration of a Genetic Medicine Directing Organ Regeneration in Heart Failure

Part of paid clinical trials in Houston, Texas.

Sponsor
YAP Therapeutics, Inc.
Study ID
NCT06831825
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • YAP101 (AAV9-Sav-shRNA) — COMBINATION_PRODUCT
    YAP101 delivered using YAPCATH-101

Study Details

This clinical trial investigates the safety and preliminary effectiveness of YAP101, a gene therapy designed to improve heart function in adults with ischemic heart failure and reduced ejection fraction (HFrEF). Ischemic heart failure, often resulting from a prior heart attack, leads to poor heart function and quality of life. Current treatments are limited, and there is an urgent need for new therapies. YAP101 works by delivering a gene therapy using a specialized vector to heart cells, targeting a pathway involved in heart repair. By temporarily activating heart muscle regeneration, YAP101 aims to restore damaged tissue, reduce scarring, and improve the heart's pumping ability. The study will enroll participants who will receive a one-time dose of YAP101 via a minimally invasive cardiac injection. Researchers will monitor participants over 12 months to assess safety and changes in heart function, exercise tolerance, and quality of life.

Key Dates

Start date
Apr 23, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: 5e12 vg YAP101
    3 to 6 subjects
  • Experimental: Cohort 2: 1e13 vg YAP101
    3 to 6 subjects
  • Experimental: Cohort 3: 5e13 vg YAP101
    3 to 6 subjects
  • Experimental: Cohort 4 (Dose Level Expansion): Dose level TBD
    Up to 6 subjects

Primary Outcome Measure

Incidence of the following: DLTs and AEs [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Heart InstituteHoustonTexas77030
Clinical Research Operations Specialist
[email protected]
832-355-9614
Center for Clinical Research
[email protected]
832-355-9405
Alexander Postalian, MD (PRINCIPAL_INVESTIGATOR)
Emerson Perin, MD (SUB_INVESTIGATOR)
Jorge Escobar, MD (SUB_INVESTIGATOR)
Nikolaos Diakos, MD (SUB_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Texas Heart Institute· Houston, TX

Related Studies