GM-CSF Knockout CAR-T Cells for Cancer Therapy

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Solution Overview

Problem

Current chimeric antigen receptor T cell (CART) therapies for cancer, such as CD19-directed CART cells, are limited by toxicities like cytokine release syndrome (CRS) and neurotoxicity, and have only 40% durable remissions in lymphoma and 50-60% in acute leukemia, due to elevated GM-CSF levels.

Innovation Solution

A method involving a nucleic acid construct with a guide RNA complementary to GM-CSF mRNA, a Cas nuclease, and a chimeric antigen receptor is introduced into T cells to reduce GM-CSF expression, using CRISPR/Cas9 technology, specifically targeting exon 3 of the GM-CSF gene, resulting in GM-CSF knockout (KO) CART cells that maintain antitumor activity without CRS and neurotoxicity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If CART cells are administered to treat cancer, then antitumor activity is improved, but cytokine release syndrome and neurotoxicity occur due to elevated GM-CSF levels

Engineering Contradiction:
Improveantitumor activityVSAvoidcytokine release syndrome and neurotoxicity
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts and removes the harmful GM-CSF component from the CART cell system by introducing a nucleic acid construct that knocks out GM-CSF expression. This selectively eliminates the harmful factor (GM-CSF) while preserving the beneficial antitumor activity of the CART cells through the retained CAR signaling domains.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the expression parameter of GM-CSF from elevated to reduced/eliminated levels by modifying the nucleic acid sequence in the CART cell. This parameter change (GM-CSF expression level) directly resolves the contradiction by removing the cause of toxicity while maintaining therapeutic function.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If standard CART cell therapy is used, then cancer treatment efficacy is achieved, but durable remission rates are limited to 40-60%

Engineering Contradiction:
Improvecancer treatment efficacyVSAvoiddurable remission
Core Design Contradiction:
ReliabilityVSDuration of action of moving object

Solution Approach 1:

The patent changes the GM-CSF expression parameter in CART cells to improve persistence and durability of the therapy. By reducing GM-CSF levels, the modified CART cells achieve enhanced long-term survival and persistence in the patient, thereby extending the duration of therapeutic action and improving durable remission rates.

Inventive Principle:
Principle #35Parameter changes

3Object-affected harmful factors

If GM-CSF expression is reduced in CART cells, then toxicity is decreased, but antitumor activity must be maintained

Engineering Contradiction:
ImprovetoxicityVSAvoidantitumor activity
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent selectively extracts only the harmful GM-CSF function from the CART cell while preserving all essential antitumor functions. The nucleic acid construct is designed to knock out specifically the GM-CSF coding sequence, leaving intact the CAR antigen recognition domains and other cytotoxic machinery needed for antitumor activity.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent converts the harmful effect of GM-CSF elevation into a benefit by using the knowledge of GM-CSF's role in toxicity to deliberately eliminate it. The harmful GM-CSF expression is transformed into a targeted knockout, converting the source of harm into a therapeutic improvement while maintaining or enhancing overall antitumor efficacy.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into 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

GM-CSF KO CART cells demonstrate enhanced antitumor activity, reduced GM-CSF production, and improved therapeutic window with durable disease control in leukemia models, while avoiding CRS and neurotoxicity, indicating a safer and more effective CART cell therapy.

Implementation Method 1

A method involving a nucleic acid construct with a guide RNA complementary to GM-CSF mRNA, a Cas nuclease, and a chimeric antigen receptor is introduced into T cells to reduce GM-CSF expression, using CRISPR/Cas9 technology, specifically targeting exon 3 of the GM-CSF gene

Methodology Applied
Scientific EffectCRISPR/Cas9 gene editing:

Data Source

PatentEP3801563B1Materials and methods for treating cancer
Publication Date: 2023.07.12 MAYO FOUNDATION FOR MEDICAL EDUCATION & RESEARCH
  • EP3801563B1 patent drawingFigure 1
  • EP3801563B1 patent drawingFigure 2A~2B
  • EP3801563B1 patent drawingFigure 3

AI summary

This document provides methods and materials involved in treating cancer. For example, chimeric antigen receptor T cells having reduced levels of GM-CSF are provided. Also provided as methods for making and using chimeric antigen receptor T cells having reduced levels of GM-CSF.