Trial Profile

A Phase 1/2 Dose-Escalation Trial to Evaluate Safety, Tolerability, and Efficacy of a Single Dose of CAP-003 Gene Therapy Administered to Patients With Parkinson's Disease With GBA1 Gene Mutation (PD-GBA)

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 23 Sep 2025

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At a glance

19 Aug 2025 Status changed from not yet recruiting to recruiting.
11 Jun 2025 According to Capsida Biotherapeutics media release, Company is initiating the Phase 1/2 study for CAP-003, with the first patient expected to be dosed in the third quarter of this year.
11 Jun 2025 According to Capsida Biotherapeutics media release, the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CAP-003, its potential best-in-class intravenously (IV) administered gene therapy, to enter clinical trials for Parkinson disease associated with GBA mutations.

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