Objective:

To introduce 'clinical MAPPs', an optimized assay for identifying MHC-II receptor-associated antibody-derived peptides in patients, aimed at enhancing personalized healthcare and assessing immunogenicity risks associated with therapeutic monoclonal antibodies.

Approach:

• Assay Development: Clinical MAPPs is a miniaturized version of the MAPPs assay designed for clinical use, utilizing cryopreserved peripheral blood mononuclear cells from low blood volumes (10 mL).
• Proof-of-Concept: The feasibility of clinical MAPPs was demonstrated by comparing peptide presentation and activation profiles in healthy individuals and patients in clinical trials, showing comparable results.

Key Findings:

• Clinical MAPPs enables personalized characterization of MHC-II receptor-associated antibody-derived peptides before monoclonal antibody treatment, allowing for tailored immunogenicity assessments.
• The assay maintains functionality with lower cell numbers and frozen samples, addressing limitations of traditional MAPPs.

Interpretation:

Clinical MAPPs represents a significant advancement in assessing immunogenicity risks associated with therapeutic monoclonal antibodies.

Limitations:

• The study primarily focuses on a proof-of-concept without extensive clinical validation, limiting the generalizability of the findings.
• The assay's effectiveness in diverse patient populations and various therapeutic monoclonal antibodies remains to be fully established.

Conclusion:

Clinical MAPPs may facilitate monitoring and management of anti-drug antibody onset in patients, contributing to the development of tailored treatment plans.