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Study identifier: NCT06818838 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Clinical Study Evaluating LY-M001 Injection in the Treatment of Adult Patients With Type I Gaucher Disease

Condition: Gaucher Disease Type 1  ·  Sponsor: Lingyi Biotech Co., Ltd.

PhasePhase 1/Phase 2
Planned participants12
Who can joinAll sexes, 18 Years to 60 Years
Healthy volunteersNo

About this study

Gaucher disease (GD) is caused by mutations in the GBA1 gene, which leads to a lack or reduction of GCase activity. The consequences of this deficiency are generally attributed to the accumulation of the GCase substrate, Glucosylceramide (GlcCer), in macrophages in the liver, spleen, kidney, bone, lung, and even the brain, inducing their transformation into Gaucher cells whose cell cytoplasm presenting a characteristic "crumpled tissue paper" appearance, leading to pathological changes in involved tissues and organs.LY-M001 Injection is an rAAV8 vector gene therapy product. It can specifically transduce the target organ liver after a single intravenous administration and express the GCase protein in liver cells for a long period of time.

This description comes directly from the study's public registry record.

Talk to the study team

Qing Lin, PhD  ·  86+19121572057  ·  qing.lin@lingyimed.com

Yixiong Chen, PhD  ·  86+19121572057  ·  yixiong.chen@lingyimed.com

Always discuss trial participation with your own doctor first.

Locations (3)

Guangzhou First People's HospitalGuangzhou, Guangdong, ChinaRecruiting
Shanxi Bethune HospitalTaiyuan, Shanxi, ChinaRecruiting
Hematology Hospital, Chinese Academy of Medical SciencesTianjin, Tianjin Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06818838