Trial Profile

A Phase 1-2, Open-label, Dose Escalation Study to Evaluate the Safety of 2 Doses of Intravenous ATA-200, an Adeno-associated Viral Vector Carrying the Human SGCG Gene, in Patients with Gamma-sarcoglycanopathy (LGMDR5)

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 11 Apr 2025

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At a glance

26 Mar 2025 According to Atamyo Therapeutics media release, first authorization of a Clinical Trial Application (CTA) in Europe for ATA-200, for treatment of y-sarcoglycan related limb-girdle muscular dystrophy Type 2C/R5 (LGMD2C/R5). This authorization was first granted by the Italian Medicines Agency (AIFA), then by the French Medicines Agency (ANSM).
14 Feb 2025 Planned initiation date (estimated date for recruitment of the first subject) changed from 31 Jan 2025 to 15 Feb 2025.
14 Feb 2025 Status changed from not yet recruiting to recruiting.

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