Phase 3 study · Spur Therapeutics · NCT07223944
Spur Therapeutics' phase 3 FLT201 study for Gaucher disease
About 45 adults with type 1 Gaucher disease are planned, and each gets FLT201 gene therapy once, as an infusion into a vein. There is no placebo, and the study tests FLT201 after participants stop enzyme replacement or substrate reduction therapy.
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Hear when Spur Therapeutics' phase 3 FLT201 study opens near you
One email when it starts enrolling or lists a new site, with the sites and how to reach the study team. Nothing else.
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Check the main requirements privately
These questions restate the study's public listing in plain words. Your answers stay on this device and are never sent. You can print a one-page summary to go over with your Gaucher specialist.
1. Are you 18 or older?
2. Has a doctor diagnosed you with type 1 Gaucher disease?
3. Have you been on enzyme replacement therapy (ERT) or substrate reduction therapy (SRT) without a break for at least 2 years?
Examples of ERT, given by infusion, are imiglucerase (Cerezyme), velaglucerase alfa (VPRIV) and taliglucerase alfa (Elelyso). Examples of SRT, taken by mouth as capsules, are eliglustat (Cerdelga) and miglustat (Zavesca).4. Have your hemoglobin and platelet counts been steady on your current treatment?
The listing asks for steady counts at the start of the study but does not say how steady. Your Gaucher specialist's office can tell you your recent blood count results.5. Has a doctor ever said you have, or might have, type 2 or type 3 Gaucher disease?
6. Have you had your whole spleen removed, an operation called a total splenectomy?
The listing names only a total splenectomy and says nothing about removal of part of the spleen.7. Have you ever had a gene therapy or a cell therapy, for Gaucher disease or anything else?
The study team also checks for these, which are easier to go over with your Gaucher specialist:
- A positive test for AAVS3 neutralizing antibodies
- A stem cell or bone marrow transplant, or any solid organ transplant, at any time
- A positive pregnancy test, or breastfeeding
- Abnormal lab values, conditions or diseases that would make the study unsuitable for the participant
- More inclusion and exclusion rules in the full study protocol, which the public listing does not spell out
Sites and contact
US sites from the public ClinicalTrials.gov record, refreshed every hour. Only the study team decides who can join.
- Kaiser Permanente - CALos Angeles, California · Recruiting
- UCLA HealthLos Angeles, California · Recruiting
- University of California, San Francisco (UCSF)San Francisco, California · Recruiting
- University of Colorado AnschutzAurora, Colorado · Recruiting
- Emory HealthcareAtlanta, Georgia · Recruiting
- University of Iowa Health CareIowa City, Iowa · Not yet recruiting
- University of MinnesotaMinneapolis, Minnesota · Recruiting
- Hackensack University Medical CenterHackensack, New Jersey · Recruiting
- NYU Langone HealthNew York, New York · Recruiting
- Duke University Medical CenterDurham, North Carolina · Recruiting
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio · Not yet recruiting
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania · Recruiting
- UPMC Children's Hospital of PittsburghPittsburgh, Pennsylvania · Recruiting
- University of Texas SouthwesternDallas, Texas · Recruiting
- Lysosomal Rare Disorders Research and Treatment CenterFairfax, Virginia · Recruiting
Every site's own contact and the full eligibility list are on the official ClinicalTrials.gov listing for NCT07223944.
Questions people ask about Spur Therapeutics' phase 3 FLT201 study
Is Spur Therapeutics' phase 3 FLT201 study enrolling now?
ClinicalTrials.gov lists it as recruiting, as of its last update there on 2026-10-14. Only the study team can confirm whether a particular site is still taking people.
Where are the US sites for Spur Therapeutics' phase 3 FLT201 study?
The listing names 15 US sites, in California, Colorado, Georgia, Iowa, Minnesota, New Jersey and 6 other states. The full list is in the sites section of this page.
Who can join Spur Therapeutics' phase 3 FLT201 study?
About 45 adults with type 1 Gaucher disease are planned, and each gets FLT201 gene therapy once, as an infusion into a vein. The main listed requirements are in the pre-check on this page, starting with: adults 18 and older at screening. Only the study team decides who can join.
How do I contact the Spur Therapeutics' phase 3 FLT201 study team?
The listing names this contact: Spur Clinical Trials Contact, +44 (0)1438 906870, clinicaltrials@spurtherapeutics.com. Each site may also list its own contact on ClinicalTrials.gov.
Is Trial Friend part of this study?
No. Trial Friend is independent of this study and its sponsor, Spur Therapeutics. This page restates the public listing in plain words, and nothing here is medical advice; talk with your Gaucher specialist about whether a study is right for you.
From the public ClinicalTrials.gov record NCT07223944, last updated there 2026-10-14. Questions checked against the listing on November 10, 2026. Trial Friend is independent of this study and its sponsor, and is not a medical provider. Nothing here is medical advice; talk with your Gaucher specialist about whether a study is right for you.