Open-Label Extension Study to Assess GLM101 in PMM2-CDG Patients

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Glycomine, Inc.
Study ID
NCT06657859
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Phosphomannomutase 2 Deficiency
  • Pmm2-CDG

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GLM101 — DRUG
    GLM101 IV infusion

Study Details

The goal of this clinical trial is to provide continued access to GLM101 to treat PMM2-CDG in people who have previously received GLM101 in other trials and learn about the long term effect of GLM101. Participants will complete weekly infusions of GLM101 at the same dose level received in previous trials.

Key Dates

Start date
Sep 30, 2024
Status verified
Jul 2026
Primary completion
Sep 30, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 30 mg/kg GLM101
    GLM101 IV infusions, given weekly

Primary Outcome Measure

Evaluate long-term safety [ Time Frame: From enrollment to end of treatment up to 4 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455-
The Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
The Children's Hospital of Philadelphia (CHOP)PhiladelphiaPennsylvania19104-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Minneapolis, MN

By research site
University of Minnesota· Minneapolis, MNThe Icahn School of Medicine at Mount Sinai· New York, NYThe Children's Hospital of Philadelphia (CHOP)· Philadelphia, PASeattle Children's Hospital· Seattle, WA