CD4+ Immune Cell Frequency Assessment for CAR T Therapy Response
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Solution Overview
Problem
Current methods for predicting and monitoring the response to chimeric antigen receptor (CAR) T cell therapy in cancer treatment are inadequate, lacking effective means to assess which patients are likely to benefit from the therapy.
Innovation Solution
Assessing the frequency of CD4+ immune cells in biological samples, such as tumor biopsy samples, using techniques like immunohistochemistry, to determine a threshold value that indicates a patient's likelihood of achieving a response to CAR T cell therapy, and tailoring treatment regimens accordingly.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current methods are used for predicting response to CAR T cell therapy, then treatment can be administered, but the ability to identify patients likely to benefit is inadequate
Solution Approach 1:
The patent applies preliminary action by assessing CD4+ immune cell frequency in tumor biopsy samples obtained before CAR T cell therapy administration. This pre-treatment biomarker assessment enables identification of patients likely to benefit from therapy, allowing treatment decisions to be made based on predictive information rather than waiting for post-treatment response data.
Solution Approach 2:
The patent uses CD4+ immune cell frequency as an intermediary biomarker that mediates between the tumor microenvironment and therapy response prediction. This biomarker serves as a measurable indicator that correlates with therapeutic outcome, enabling reliable prediction without directly measuring therapy response mechanisms.
2Measurement precision
If CD4+ immune cell frequency is assessed in tumor samples, then patient selection accuracy improves, but the complexity of assessment procedures increases
Solution Approach 1:
The patent extracts and focuses on a specific subset of immune cells (CD4+ cells) within the complex tumor microenvironment. By isolating this particular cell population for frequency assessment, the method achieves precise predictive capability without requiring comprehensive analysis of all tumor components, thereby reducing overall assessment complexity.
Solution Approach 2:
The patent applies local quality by concentrating the assessment on a specific local feature (CD4+ immune cell frequency) within the tumor sample rather than requiring global characterization of the entire tumor. This targeted approach maintains high prediction accuracy while simplifying the assessment procedure to focus on one critical biomarker.
3Reliability
If treatment regimens are tailored based on biomarker assessment, then treatment effectiveness improves, but the time required for assessment and decision-making increases
Solution Approach 1:
The patent performs the CD4+ immune cell frequency assessment as a preliminary step before treatment administration. By completing this biomarker evaluation in advance, the system enables timely treatment decisions while ensuring that treatment effectiveness is optimized based on patient-specific predictive data, balancing time requirements with therapeutic benefit.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach allows for personalized treatment decisions by identifying patients likely to achieve a complete or partial response to CAR T cell therapy, potentially leading to more effective and durable outcomes.
Implementation Method 1
the CD4+ immune cells are detected using immunoassay, in situ hybridization, immunohistochemistry, multiplexed immunohistochemistry, or 5-plex immunofluorescent immunohistochemistry
Data Source
AI summary
Provided are methods and articles of manufacture for use with cell therapy for the treatment of diseases or conditions, e.g., cancer, including for predicting likelihood of the subject responding to a therapy, such as a cell therapy, e.g., a chimeric antigen receptor (CAR) T cell therapy. In some aspects, the predicting is based on detecting certain biomarkers of immune cells associated with and/or that correlate with response following administration of the therapy. The methods generally involve detecting a marker by assaying a biological sample from a subject that is a candidate for treatment, optionally with a cell therapy, to determine if the subject is likely to respond to the therapy. The present disclosure also provides methods for treating a subject having a disease or condition, in some cases involving administration of the cell therapy, based on assessment the biomarker. Also provided herein are reagents and kits for performing the methods.