Phase 1 Study of GC1130A in Patients With Sanfilippo Syndrome Type A (MPS IIIA)

NCT ID: NCT06567769

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-21

Study Completion Date

2027-06-30

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of recombinant human heparan N-sulfatase (rhHNS, GC1130A) administered via intracerebroventricular access device in patients with Sanfilippo Syndrome Type A (MPS IIIA).

Detailed Description

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Conditions

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Sanfilippo Syndrome Type A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

GC1130A

Intervention Type DRUG

ICV injection

Cohort 2

Group Type EXPERIMENTAL

GC1130A

Intervention Type DRUG

ICV injection

Cohort 3

Group Type EXPERIMENTAL

GC1130A

Intervention Type DRUG

ICV injection

Interventions

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GC1130A

ICV injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants with documented MPS IIIA diagnosis
* Participants aged ≥ 12 months and ≤ 18 years

Exclusion Criteria

* Participants with significant non-MPS IIIA related central nervous system impairment
* Participants with previous complication from intraventricular drug administration
* Participants with contraindications for MRI scans and for neurosurgery
* Participants that received treatment with any investigational drug or a device intended as a treatment for MPS IIIA within 30 days or 5 half-lives prior to the study
* Participants that received a hematopoietic stem cell or bone marrow transplant or received gene therapy
Minimum Eligible Age

12 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GC Biopharma Corp

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCSF Benioff Children's Hospital

Oakland, California, United States

Site Status RECRUITING

University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

National Center for Child Health and Development

Setagaya City, Tokyo, Japan

Site Status RECRUITING

Ajou University Medical Center

Suwon, Gyeongi-do, South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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United States Japan South Korea

Central Contacts

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GC Biopharma Corp.

Role: CONTACT

+82312609300

Facility Contacts

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Mariam Samara

Role: primary

510-428-3885 ext. 4785

Brenda Diethelm-Okita

Role: primary

612-625-1594

Melissa Fetterley

Role: backup

612-672-5151

Bora Lim

Role: primary

+82312194404

Minji Im, MD

Role: primary

+82234103757

Other Identifiers

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GC1130_MPS3A_P0101

Identifier Type: -

Identifier Source: org_study_id

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