Immune Globulin for Primary Immunodeficiency

Not currently recruiting at 7 trial locations

Overseen By Hyejoo Kim

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: GC Biopharma Corp

Must be taking: IGIV therapy

Disqualifiers: IgA deficiency, Secondary immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called GC5107 (an immune globulin therapy) to evaluate its effectiveness and safety for children with Primary Humoral Immunodeficiency (PHID), a condition that impairs the body's ability to fight infections. The study examines a medication administered through an IV to enhance the immune system. Eligible children must have a confirmed PHID diagnosis and a history of using similar treatments without issues. As a Phase 3 trial, this treatment represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking therapy.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must have been on a specific dose of IGIV therapy for at least 3 months before the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that GC5107, a 10% liquid administered through an IV to boost the immune system, is generally safe for individuals with primary immunodeficiency. In a study involving 63 patients, the treatment proved effective and safe. Most patients tolerated it well, experiencing only minor side effects such as headaches and nausea. These findings suggest that the treatment does not cause serious side effects for most individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

GC5107 is unique because it offers a new formulation of immune globulin, delivered intravenously as a 10% liquid solution. Unlike some current treatments that might have varying concentrations or forms, this specific formulation might enhance the delivery and effectiveness of the immune globulin, potentially providing more consistent and reliable results for people with primary immunodeficiency. Researchers are excited about GC5107 because it could streamline the treatment process and improve patient outcomes by ensuring a stable and potent administration of the essential proteins needed to bolster the immune system.

What evidence suggests that GC5107 might be an effective treatment for Primary Humoral Immunodeficiency?

Research has shown that GC5107, the treatment under study in this trial, effectively treats primary immunodeficiency. Several studies confirm that this immune globulin product is safe and well-tolerated by patients. These studies found that GC5107 helps the immune system better fight infections in people with this condition. The treatment, a 10% liquid solution, proved effective in earlier trials. Overall, this provides strong evidence supporting its use for managing primary immunodeficiency. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for kids aged 2 to 16 with Primary Humoral Immunodeficiency. They must have been treated with IGIV therapy regularly and have certain levels of IgG in their blood. Kids can't join if they've had bad reactions to IGIV, received other blood products recently, have secondary immunodeficiencies, or participated in a non-IGIV study within the last 3 weeks.

Inclusion Criteria

Subject must be ≥ 2 to < 17 years of age, at the time of signing the informed consent

Pediatric subject has a confirmed and documented clinical diagnosis of Primary Humoral Immunodeficiency, including hypogammaglobulinemia or agammaglobulinemia

Subject who has received 300 - 900 mg/kg of IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study

Exclusion Criteria

You have had serious allergic reactions or hypersensitivity to IGIV or other types of injectable IgG in the past.

Subject who has received blood products other than human albumin or human immune globulin within 6 months prior to enrollment

You have a weakened immune system due to another medical condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous infusions of GC5107 every 21 or 28 days

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GC5107

Trial Overview The trial tests GC5107, an intravenous immune globulin treatment on children with PHID. It aims to understand how the drug moves through and affects young bodies while checking its safety at different doses.

How Is the Trial Designed?

Group I: GC5107 Experimental Treatment 1 Intervention

Immune Globulin Intravenous (Human), 10% Liquid

Who Is Running the Clinical Trial?

GC Biopharma Corp

Lead Sponsor

Trials

10

Recruited

660+

Green Cross Corporation

Lead Sponsor

Trials

82

Recruited

24,000+

Il-Sub Huh

Green Cross Corporation

Chief Executive Officer since 2023

MBA from Seoul National University

Heo Yong-jun

Green Cross Corporation

Chief Medical Officer since 2023

MD from Yonsei University

Atlantic Research Group

Collaborator

Trials

9

Recruited

600+

Citations

1. gcbiopharma.us gcbiopharma.us/news-PhaseIII_Results.html

Newsroom. The peer-reviewed publication of the GC5107 study demonstrates that this novel 10% IgG formulation is safe, effective, and well-tolerated in adolescent and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34305948/

Efficacy, Safety and Tolerability of a New 10% Intravenous ... Results of the present study demonstrate that GC5107 is an effective, safe and well-tolerated treatment for patients with primary immunodeficiency.

3. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2021.707463/full

Efficacy, Safety and Tolerability of a New 10% Intravenous ... Results of the present study demonstrate that GC5107 is an effective, safe and well-tolerated treatment for patients with primary immunodeficiency.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00157079

NCT00157079 | Safety and Efficacy Study of a 10% ... The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8297997/

Efficacy, Safety and Tolerability of a New 10% Intravenous ... Results of the present study demonstrate that GC5107 is an effective, safe and well-tolerated treatment for patients with primary immunodeficiency.

6. gammagard.com gammagard.com/hcp/pidd/safety

GAMMAGARD LIQUID 10% IVIG & SCIG Safety & ARs | HCP Review GAMMAGARD LIQUID 10% safety for primary immunodeficiency (PI), including IVIG/SCIG adverse reactions from clinical studies.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3389237/

Safety, Efficacy and Pharmacokinetics of a New 10 ... An investigational 10% liquid intravenous immunoglobulin (IVIG) was studied in 63 patients with primary immunodeficiency (PID) at 15 study sites.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04565015

Study of Immune Globulin Intravenous (Human) GC5107 in ... The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary ...