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Open-Label Extension Study of GLM101 for PMM2-CDG

This study is for people with PMM2-CDG (Phosphomannomutase 2 Deficiency), a rare genetic disorder, who have previously received GLM101 in another clinical trial. The main goal is to understand the long-term safety of GLM101, given as an intravenous (IV) infusion, and to continue providing this treatment. You would receive weekly infusions of GLM101 at the same dose you received before. Researchers will also look at how GLM101 affects symptoms like ataxia (problems with coordination) and your quality of life. The study plans to enroll 90 participants, and its current status is unclear.

Study design
This is an open-label study, meaning both you and the study team will know you are receiving GLM101. It is designed to monitor the long-term safety and effects of GLM101.
What's involved
You would receive weekly GLM101 IV infusions. You will also complete questionnaires to assess changes in ataxia and quality of life.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate long-term safety from enrollment up to 4 years after treatment begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06657859

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

Enrolling by Invitation
PHASE2Ages 2+InterventionalTreatment
Glycomine, Inc.
~90 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:GLM101

At a glance

Recruiting sites
0 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate long-term safety
Measured over From enrollment to end of treatment up to 4 years

Conditions

Pmm2-CDG
Phosphomannomutase 2 Deficiency

Explore related trials

Congenital Disorder of Glycosylation Type IaPMM2 Gene

Where it's being run

15 sites across 11 states
Spain3
Italy2
United Kingdom2
Minnesota1
New York1
Pennsylvania1
Washington1
Czechia1

Study leadership

  • Chief Medical Officer · STUDY_DIRECTOR · Glycomine, Inc.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

If the participant is a female of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile (permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy)) or becomes of childbearing potential during the study, she must not be pregnant (confirmed by a negative serum pregnancy test), is using a medically accepted method of contraception (abstinence, a hormonal contraceptive associated with inhibition of ovulation in conjunction with a barrier method, or use of an intrauterine device), and must agree to continue using this method for 50 days after the last infusion of GLM101. Note: True abstinence: defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
If the participant is a female of non-childbearing potential, she must be pre-pubertal, surgically sterile, or must have an ovarian dysfunction confirmed by a follicle stimulating hormone (FSH) \>40 IU/L and absence of menses for 12 months without an alternative medical cause.
If the participant is a sexually active (or becomes sexually active during the study) male with female partners, the sexually mature, nonsterile male participant agrees to use a medically acceptable method of contraception (abstinence, the partner taking a hormonal contraceptive in conjunction with a male condom, or use by the partner of an intrauterine device with a male condom) and agrees to continue using this method for 50 days after the last infusion of GLM101. Males are considered surgically sterile if they have undergone bilateral orchiectomy or vasectomy at least 3 months prior to Screening. 6. If the participant is male, he must agree to refrain from donating sperm during the study and 50 days after the last infusion of GLM101. 7. Is willing and able to comply with this protocol.

What this trial measures

  • Evaluate long-term safetyFrom enrollment to end of treatment up to 4 years

    Number of participants with treatment related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0