FLT201

GENETIC5 trials

Sponsors

Spur Therapeutics Limited, Spur Therapeutics

Conditions

Gaucher Disease Type 1Gaucher Disease, Type 1

Phase 1

A Gene Therapy Study in Patients With Gaucher Disease Type 1

CompletedNCT05324943

Spur TherapeuticsGaucher Disease, Type 1

Start: 2022-04-15End: 2024-12-04Updated: 2026-06-02

A Multicenter, Long-term, Follow-up Study to Investigate the Safety and Durability of Response Following Dosing of an Adeno-associated Viral Vector (FLT201) in Subjects with Gaucher Disease (GALILEO-2)

Active, not recruitingCTIS2024-511172-33-00

Spur Therapeutics LimitedGaucher Disease Type 1

Start: 2024-05-10Target: 1Updated: 2025-10-15

Long Term Follow-up Study of Type-1 Gaucher Subjects Post FLT201 Dose (GALILEO-2)

Active, not recruitingNCT06545136

Spur TherapeuticsGaucher Disease, Type 1

Start: 2024-05-13End: 2029-05-31Target: 75Updated: 2025-11-04

Phase 3

A Gaucher Disease Gene Therapy Trial With FLT201

RecruitingNCT07223944

Spur TherapeuticsGaucher Disease Type 1

Start: 2026-04-07End: 2032-10-01Target: 45Updated: 2026-09-03

A Phase 3 Safety and Efficacy Trial of FLT201 Gene Therapy in Patients with Gaucher Disease Type 1

Not yet recruitingCTIS2025-520765-50-00

Spur Therapeutics LimitedGaucher Disease Type 1

Target: 4Updated: 2026-09-08

Related Papers

Trial in progress: Galileo-3, a Phase 3 safety and efficacy trial of FLT201 gene therapy in patients with gaucher disease type 1

Blood2025-11-03

GALILEO-1: A Phase I/II Safety and Efficacy Study of FLT201 Gene Therapy for Gaucher Disease Type 1

Future Rare Diseases2023-01-139 citations