Drug intelligence / Profile preview

Immune Globulin Infusion (Human)

Development stage
Approved
Lead developer
GC Biopharma USA
Modality
Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

Standard immunoglobulin replacement therapy (IVIG) is a biologic product consisting of pooled human immunoglobulin G (IgG) antibodies derived from donor plasma. It is used to provide passive immunity in patients with primary or secondary immunodeficiencies. In a Phase II clinical trial (NCT04562025) led by the Fred Hutchinson Cancer Center, IVIG is being evaluated for its ability to prevent infectious complications in patients who have received CD19-targeted chimeric antigen receptor (CAR) T-cell therapy. CD19 CAR-T therapies often result in prolonged B-cell aplasia and subsequent hypogammaglobulinemia (low IgG levels), which significantly increases the risk of severe bacterial and viral infections. IVIG therapy aims to replenish protective antibody levels and reduce the incidence of infection-related morbidity in this patient population.

Other names
IVIGIntravenous ImmunoglobulinImmunoglobulin Replacement TherapyImmune Globulin Infusion (Human), 10% Solution
02

Targets

FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)Neuraminidase

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