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.
Original patent title: “Determining toxicity risk 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. Granted to Juno Therapeutics in 2024 with 30 claims, and it is expected to expire in 2038.
Coverage
What does this patent actually cover?
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 (ClaimclaimA numbered sentence at the end of a patent that legally defines what the inventor owns. The most important section.Read more → 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.
The gap
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.
- 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.
These exclusions are unique to PatentBrief — derived from the actual claim language, not patent-office boilerplate.
Key facts
What made this novel
The noveltynoveltyThe requirement that an invention be different from anything publicly known before its priority date.Read more → 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.
The Patent Drawing
Schematic visualization of the patent's claim structure. Hand-drawn diagrams in progress for each landmark patent.
Where you've seen this
Real-world examples
Kymriah (tisagenlecleucel) for ALL and DLBCL
Yescarta (axicabtagene ciloleucel) for DLBCL and follicular lymphoma
Tecartus (brexucabtagene autoleucel) for mantle cell lymphoma and ALL
Most modern CAR T-cell therapy treatment protocols
Why it matters
The bigger picture
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.
Filed
February 27, 2018
Granted
December 10, 2024
Market context
Who's building on this
Companies in this space
Juno Therapeutics, the original assigneeassigneeThe entity that owns the patent — usually the inventor's employer or a company.Read more →, is now part of Bristol Myers Squibb, a major pharmaceutical company. Other leading companies in the CAR T-cell therapy space, such as Novartis and Kite Pharma (a Gilead company), are continuously researching and developing improved methods for managing the safety and efficacy of their cell therapies. This includes refining patient selection, monitoring, and toxicity management protocols.
Market impact
The ability to predict and manage severe toxicities like CRS and neurotoxicity is fundamental to the success and expansion of CAR T-cell therapies. Patents like this contribute to the safety profiles of these treatments, which in turn supports regulatory approvals and broader patient access. It helps differentiate therapies by offering improved safety management protocols, a key factor in a competitive and rapidly evolving therapeutic area for blood cancers.
Claim 1 — Plain English
What this patent covers
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.
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.
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.
Patent timeline
Application submitted to the patent office
Application published, typically 18 months after filing
Patent officially issued
Patent enters public domain
PatentBrief Score
Impact Score
Moderate
Citation count
0/40
No citations yet
Claim breadth
20/20
Very broad protection
Recency
20/20
Granted within 5 years
Assignee scale
0/20
Independent or smaller assigneeassigneeThe entity that owns the patent — usually the inventor's employer or a company.Read more →
PatentBrief Impact Score — based on citation count, claim breadth, recency, and assignee scale. Not a legal assessment.
Heuristic Value Estimate
What this patent might be worth
$73K – $234K
Midpoint $146K · 11.6 yr remaining · industry ×3.0
Heuristic only — blends forward/backward citation counts, claim scope, time remaining, litigation history, and CPC-derived industry baseline. Real valuations need a professional appraisal.
Claim text not yet imported for this patent
The original legal language
Original claims
30 claims as filed with the patent office.
Concepts involved
Citations
Patent lineage
Cite this patent
Gilbert, M., Yee, N., Jr., R. J. G., CHRISTIN, B., WALKER, A. W., Odegard, V., CHARTRAND, N., LARSON, R. P., RAMSBORG, C. G., KOWSKI, T., Smith, J., LAMBERT, N., TREDE, N. S., DAVIS-PICKETT, M., MALLANEY, M., Blackman, S. C., Pollock, K. L., COVINGTON, M. G., WEBER, C., ..., & BECKETT, T. (2024). Predicting and Treating Dangerous Side Effects in CAR T-Cell Therapy (U.S. Patent No. 12,163,952). U.S. Patent and Trademark Office. https://patentbrief.org/patent/us/12163952/determining-toxicity-risk-in-car-t-cell-therapy
Auto-generated from the patent record. Double-check author order and the issue date against the official USPTO document before submitting.
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Common Questions
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.
Patent monitoring