NCT07516002

Immunoglobulin Efficacy and Immune Profiling in Antibody Immunodeficiency

Real-world Efficacy of Immunoglobulin in Antibody Immunodeficiency: A Prospective Cohort Study Based on T/B Cell Subset Profiling

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

This study aims to systematically evaluate the dynamic alterations in peripheral immune subsets among patients with antibody Immunodeficiency undergoing Immunoglobulin therapy

Detailed description

Antibody Immunodeficiency（AID） represent a heterogeneous group of inborn errors of immunity characterized by defective antibody production, predisposing patients to recurrent infections, chronic inflammation, and paradoxical autoimmune manifestations. While Immunoglobulin replacement therapy serves as the cornerstone of management, patient clinical trajectories and responses to treatment remain highly variable. The underlying immunological defects-particularly the impaired cross-talk between T and B lymphocytes-are critical to understanding the pathogenesis and phenotypic diversity of AID. This single-center, prospective observational study is designed to systematically characterize the dynamic alterations in peripheral immune subsets among patients with antibody immunodeficiency, with a specific focus on T-B cell interactions. By employing high-resolution multiparametric flow cytometry, we will perform comprehensive profiling of critical lymphocyte subpopulations. B-cell evaluation will quantify switched memory B cells, non-switched memory B cells, plasmablasts, and double-negative B cells. Concurrently, T-cell profiling will assess circulating follicular helper T cells (pTfh), regulatory T cells (Tregs), and overarching CD4+ and CD8+ compartments. Participants will undergo baseline clinical and immunological evaluation prior to or during steady-state immunoglobulin therapy, followed by prospective longitudinal assessments. We hypothesize that specific baseline immune signatures (e.g., skewed pTfh proportions or expanded DN B cells) may serve as predictive biomarkers for the frequency of breakthrough infections and the development of autoimmune complications. Furthermore, this study will investigate the potential long-term immunomodulatory effects of immunoglobulin on restoring cellular homeostasis. Ultimately, by correlating deep immunophenotyping data with real-world clinical outcomes-specifically annualized infection rates, specific antibody responses, and IgG trough levels-this study aims to elucidate the mechanisms driving clinical heterogeneity in AID and provide an evidence base for more personalized, targeted therapeutic strategies.

Conditions

• Primary Immunodeficiency Diseases

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-10-01
• Completion: 2029-12-30
• First posted: 2026-04-07
• Last updated: 2026-04-07