Selection of patients with hypogammaglobulinemia for immunoglobulin replacement therapy

By analyzing B cell receptor repertoires in patients with low serum IgG, the method identifies those needing IgG-RT based on antibody sequence diversity and maturity, addressing the challenge of patient selection for immunoglobulin therapy.

JP2026505711APending Publication Date: 2026-02-18GIGAGEN INC +1
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Patent Information

Application Number
JP2025540924
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-01-13
Filing Date
2024-01-12
Publication Date
2026-02-18

AI Technical Summary

Technical Problem

Existing methods struggle to accurately identify patients with hypogammaglobulinemia who require immunoglobulin replacement therapy (IgG-RT), as some patients with low serum IgG levels do not exhibit infection susceptibility despite low IgG titers, while others do.

Method used

Analyze the composition and diversity of B cell receptor (BCR) repertoires in patients with low serum IgG concentrations to determine the need for IgG-RT by sequencing and characterizing IgG and IgM heavy chain BCR repertoires, assessing criteria such as diversity index, germline identity, and somatic mutation frequency.

Benefits of technology

This approach allows for precise identification of patients who require IgG-RT by distinguishing between diverse but less optimal and less diverse but more mature antibody sequences, ensuring appropriate treatment for hypogammaglobulinemia.

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Abstract

The present disclosure provides a method for selecting hypogammaglobulinemia patients in need of immunoglobulin replacement therapy (IgG-RT) by analyzing the patient's B cell repertoire. The method can be used before treating the patient with IgG-RT. The method can also include treating the patient. Also provided herein is a diagnostic product in a computer-readable medium that provides information for patient selection. The B cell repertoire can be measured by the number or abundance of individual antibody clones, by calculating a diversity index value for antibody clones, by calculating the total frequency of the 10 to 30 most frequent antibody clones, by determining the frequency of variable region gene (V region) usage in antibody clones, by measuring the percent germline identity of V or J regions in the BCR repertoire by comparing them with corresponding germline sequences, and / or by determining the somatic mutation frequency in different regions along the V region.
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