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Trials / Enrolling By Invitation

Enrolling By InvitationNCT07398872

Safety and Efficacy of AAV9. hMCOLN1co For Patients With Mucolipidosis Type IV

Evaluating the Safety and Efficacy of AAV9.hMCOLN1co in Treating Mucolipidosis Type IV: A Single-Center, Interventional, Open-Label, Single-Arm Clinical Study

Status
Enrolling By Invitation
Phase
Phase 1
Study type
Interventional
Enrollment
1 (estimated)
Sponsor
The Children's Hospital of Zhejiang University School of Medicine · Academic / Other
Sex
All
Age
18 Months – 8 Years
Healthy volunteers
Not accepted

Summary

Safety and Efficacy of AAV9.hMCOLN1co for patients with Mucolipidosis Type IV(MLIV): A Single-Center, Interventional, Open-Label, Single-Arm Clinical Study. The goal of this clinical trial is to evaluate whether a gene therapy can safely treat children with MLIV.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAAV9.hMCOLN1coA single intrathecal infusion of 10 mL at 2E13 vg/mL for a total dose of 2E14 vg

Timeline

Start date
2026-01-13
Primary completion
2027-01-20
Completion
2031-01-20
First posted
2026-02-10
Last updated
2026-02-10

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07398872. Inclusion in this directory is not an endorsement.