Trial Profile

An Open-label, Phase 1/2 Trial of Gene Therapy 4D-310 in Adults With Fabry Disease

Status: Active, no longer recruiting

Phase of Trial: Phase I/II

Latest Information Update: 14 Aug 2024

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At a glance

Drugs 4D 310 (Primary) ; Rituximab; Sirolimus
Indications Fabry's disease
Focus Adverse reactions; Proof of concept
Acronyms INGLAXA
Sponsors 4D Molecular Therapeutics

Most Recent Events

08 Aug 2024 According to 4D Molecular media release, the U.S. Food and Drug Administration (FDA) removed clinical hold on this study for 4D-310 in Fabry disease cardiomyopathy; enrollment expected to resume in H2 2024 and program update expected in 2025.
05 Apr 2024 Planned End Date changed from 1 Jun 2027 to 1 Jun 2030.
05 Apr 2024 Planned primary completion date changed from 1 Jun 2023 to 1 Jan 2026.

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