T Cell Therapy Marker Panel for Response and Manufacturing Prediction

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Solution Overview

Problem

Existing immunotherapy and cell therapy methods lack effective approaches to predict clinical responses and manufacturing outcomes for T cell therapies, particularly in cancer treatment.

Innovation Solution

A method involving the analysis of multiple blood and patient-specific markers before T cell therapy administration to predict clinical response and manufacturing effectiveness, using parameters such as d-dimer, fibrinogen, lymphocyte and monocyte levels, and other biomarkers to determine if a subject will benefit from or be suitable for T cell therapy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If T cell therapy is administered to treat cancer, then treatment efficacy may be improved, but the ability to predict clinical response is insufficient

Engineering Contradiction:

Improveclinical response prediction accuracyVSAvoidlack of predictive markers

Core Design Contradiction:

ReliabilityVSLoss of information

Solution Approach 1:

The patent performs marker analysis on patient samples before T cell therapy administration to predict clinical response. This preliminary assessment allows identification of patients likely to benefit from therapy, enabling informed treatment decisions prior to therapy initiation.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent introduces multiple blood-based markers (d-dimer, fibrinogen, lymphocytes, monocytes, and other clinical parameters) as intermediary indicators that mediate between patient characteristics and T cell therapy outcomes. These markers serve as predictive intermediaries to assess treatment likelihood.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Measurement precision

If multiple markers are analyzed to predict clinical response, then prediction accuracy is improved, but testing complexity increases

Engineering Contradiction:

Improveresponse prediction accuracyVSAvoidmarker testing complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent divides the prediction system into multiple independent marker assessments (d-dimer, fibrinogen, lymphocyte count, monocyte count, and other clinical parameters). Each marker is measured and evaluated separately, allowing comprehensive prediction while maintaining manageable individual test complexity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent uses a panel of markers that can be measured using常规 clinical laboratory methods, making the prediction system universally applicable across different healthcare settings. The same marker panel can assess multiple aspects of patient status (coagulation, immune function, organ function) simultaneously.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS20250345432A1Method for predicting response to a t cell therapy

Publication Date: 2025.11.13 CELGENE CORP

AI summary

The present disclosure relates to methods for using various markers to predict manufacturing outcomes or clinical responses of subjects, e.g., patients, to administration of a T cell therapy. In some aspects, the T cells of the T cell therapy express recombinant receptors such as chimeric receptors, e.g., chimeric antigen receptors (CARs), or other transgenic receptors, such as T cell receptors (TCRs). Also provided herein are methods for treating subjects, for instance those predicted to exhibit a clinical response.