# Predicting and Treating Dangerous Side Effects in CAR T-Cell Therapy > This patent describes methods to identify patients at high risk for severe side effects, like cytokine release syndrome or neurotoxicity, during CAR T-cell cancer therapy and how to treat them proactively. - **Patent:** US 12163952 - **Original title:** Determining toxicity risk in CAR T-cell therapy - **Owner:** Juno Therapeutics - **Granted:** 2024 - **Status:** Active - **Times cited:** 0 - **Field:** biotech, pharmaceutical, gene_editing, oncology ## What it does This patent outlines a method to reduce severe side effects, specifically severe cytokine release syndrome (CRS) or severe neurotoxicity, in patients receiving CAR T-cell therapy. The method involves administering a specific dose of CAR-expressing T cells, between 1.0x10^7 and 1x10^8 total cells. After the cells are given, the patient's blood is checked. If the CAR T-cells show a rapid expansion within about seven days (Claim 1), or if the level of interleukin-15 (IL-15) is high (at or above 30 pg/mL) within five days (Claim 2), or if specific CAR T-cell counts are met at certain days (e.g., at least 15 cells per microliter by day seven, Claim 16), the patient is identified as being at risk. Once identified, the patient is treated with an agent like a steroid (such as dexamethasone, Claim 9) or an IL-6 or IL-6 receptor inhibitor (like tocilizumab, Claim 10) to prevent or manage these severe toxicities. ## What it does NOT cover - Does not cover CAR T-cell doses outside the specified range of 1.0x10^7 to 1x10^8 total cells. - Does not cover treating toxicities other than severe cytokine release syndrome or severe neurotoxicity. - Does not cover methods of toxicity management that do not involve administering a steroid or an IL-6 or IL-6 receptor inhibitor. - Does not cover risk assessment methods that do not rely on CAR T-cell expansion timing, specific cell counts at defined days, or IL-15 levels. - Does not cover CAR T-cell therapies where the CAR targets antigens unrelated to B cell malignancies, unless they are specifically listed antigens like CD19 or CD20. ## The clever bit The novelty lies in defining specific, measurable biological indicators and precise timing thresholds (like rapid T-cell expansion within seven days or specific IL-15 levels) that reliably predict severe toxicity *before* it becomes life-threatening, allowing for timely and targeted intervention. ## Real-world examples 1. Kymriah (tisagenlecleucel) for ALL and DLBCL 2. Yescarta (axicabtagene ciloleucel) for DLBCL and follicular lymphoma 3. Tecartus (brexucabtagene autoleucel) for mantle cell lymphoma and ALL 4. Most modern CAR T-cell therapy treatment protocols ## Why it matters CAR T-cell therapy is a powerful and life-saving treatment for certain blood cancers, but it carries significant risks, particularly severe cytokine release syndrome and neurotoxicity. This patent provides a structured, data-driven approach to identify patients at high risk for these dangerous side effects early. By enabling proactive intervention with specific medications, it helps make CAR T-cell therapies safer and more manageable, which is critical for their broader adoption and success in treating diseases like leukemia and lymphoma. ## Frequently asked questions ### What does Predicting and Treating Dangerous Side Effects in CAR T-Cell Therapy cover? This patent describes methods to identify patients at high risk for severe side effects, like cytokine release syndrome or neurotoxicity, during CAR T-cell cancer therapy and how to treat them proactively. ### Who owns patent US 12163952? Juno Therapeutics owns this patent, granted in 2024. ### When does this patent expire? This patent is expected to expire on February 27, 2038, when the invention enters the public domain. ### What problem does this patent solve? CAR T-cell therapy is a powerful and life-saving treatment for certain blood cancers, but it carries significant risks, particularly severe cytokine release syndrome and neurotoxicity. This patent provides a structured, data-driven approach to identify patients at high risk for these dangerous side effects early. By enabling proactive intervention with specific medications, it helps make CAR T-cell therapies safer and more manageable, which is critical for their broader adoption and success in treating diseases like leukemia and lymphoma. ### What does this patent NOT cover? Does not cover CAR T-cell doses outside the specified range of 1.0x10^7 to 1x10^8 total cells. **Full plain-English explainer:** https://patentbrief.org/patent/us/12163952/determining-toxicity-risk-in-car-t-cell-therapy **Original patent:** https://patents.google.com/patent/US12163952 --- _Source: PatentBrief — https://patentbrief.org. Patent facts are from public records; the plain-English explanation is PatentBrief's._ ## Related patents Semantically similar inventions in the PatentBrief corpus: - [How Genetically Modified T-Cells Fight CD19 Cancers](https://patentbrief.org/patent/us/9481728/compositions-and-methods-for-treatment-of-cancer) — This patent describes how to create and use genetically modified human T cells that target and kill cancer cells expressing the CD19 protein, offering a new way to treat blood cancers. - [How Genetically Modified T-Cells Attack Cancer](https://patentbrief.org/patent/us/9328156/use-of-chimeric-antigen-receptor-modified-t-cells-to-treat-cancer) — This patent describes how human T cells are genetically engineered to express a special receptor (CAR) that specifically targets and kills cancer cells, particularly those with the CD19 marker, offering a new way to treat cancer. - [Treating Liver Cancer with Specially Trained Immune Cells](https://patentbrief.org/patent/us/12168044/peptides-and-combination-of-peptides-for-use-in-immunotherapy-against-non-small-) — This patent describes a method for treating hepatocellular cancer by giving patients specially activated immune cells that are trained to recognize and kill cancer cells displaying a specific protein fragment. - [How a Specific Protein Fragment Can Train Immune Cells to Fight Cancer](https://patentbrief.org/patent/us/10314897/peptides-and-combination-of-peptides-for-use-in-immunotherapy-against-various-ca) — This patent describes methods to fight various cancers by using a specific protein fragment (peptide LYHDIFSRL) to train a patient's immune cells to recognize and attack tumor cells. - [How Novartis Engineered Antibodies to Block the TIM-3 Immune Checkpoint](https://patentbrief.org/patent/us/10472419/keytruda-pembrolizumab) — A patent describing specific genetic blueprints for antibodies designed to bind to and inhibit the TIM-3 protein, a key target in cancer and immune system research.