Release date: 2016-03-09

Chimeric antigen receptor T (CAR-T) cell therapy is one of the biggest development hotspots in the pharmaceutical industry. The history of CAR-T has experienced several roller coaster-like experiences, and these thrills are mostly related to safety. The preparation process of CAR-T is extremely risky. Early CAR-T clinical trials led to clinical clinical hypersensitivity reactions due to quality problems during product preparation, and were repeatedly stopped by the FDA. Hypersensitivity reactions can be fatal if not addressed in time. With advances in technology, hypersensitivity is no longer the first safety consideration, and cytokines storm or cytokines release syndrome has risen to the number one safety risk. Cytokine release syndrome is a T cell-based activation that is a response to T cell activation activity, so side effects are clinically positively related to the therapeutic mechanism of CAR-T.

Currently, CAR-T cell therapy targeting CD-19 is reported in the treatment of ALL, CLL, and NHL, thanks to anti-IL-6 antibodies. In the first case of CAR-T, the sick child did not retreat. When the blood phase was checked, the IL-6 reached a hundred times normal value. Fortunately, the attending doctor thought of the anti-IL-6 antibody Tocilizumab (Actemra). After the antibody is used, high fever is controlled. If this patient died of high fever, I am afraid that CAR-T will not be able to go today.

It is well known that cytokine release syndrome is by far the most serious side effect of CAR-T treatment. During the administration of CAR-T, patients almost always occur, but to varying degrees, and the way they are handled is different. According to the CTCAE standard, grades 4-5 are extremely serious and fatal. So is there a quick test method to predict the severity of the symptoms in order to achieve effective prevention? Dr. David T Teachey from the Children's Hospital of Pennsylvania University found two prescribing biomarkers (Biomaker). Teachey analyzed the symptomatic grading of cytokine release syndrome and serum cytokine levels in 51 CAR-T-treated patients. Cytokine release syndrome occurred in 48 of 51 patients treated with CAR-T, mostly in moderate to low response. However, 14 patients developed severe cytokine release syndrome, and 21 patients received anti-IL-6 antibody therapy. Used to control high fever. A regression analysis found that two cytokines reached high peaks during the first three days of CAR-T treatment: one was interferon gamma (INFδ), and the other was a protein called Sgp-130, which is IL-6. Antagonists reflect the increase in IL-6 from the side. Dr. David T Teachey found through regression analysis that the signature features of the three cytokines were associated with cytokine release syndrome predictions, with a correlation of more than 96%. Dr. Teachey said that perhaps there is no best predictive method, but measuring several key cytokines within 48 hours is helpful for predicting and responding to severity. Simultaneous measurement of INFδ, IL-6, and sgp-130 outside the author should be simple and easy, and it is a dangerous prediction method for pre-visiting.

Researchers at the famous CAT-T cell therapy company Juno Therapeutics are also developing similar assays for predicting and preventing cytokine release syndrome. Today, as the FDA continues to raise the threshold for security, the ability to control security risks directly affects approval, and no one dares to take it lightly.

Chimeric antigen receptor T (CAR-T) cell therapy is one of the biggest development hotspots in the pharmaceutical industry. The history of CAR-T has experienced several roller coaster-like experiences, and these thrills are mostly related to safety. The preparation process of CAR-T is extremely risky. Early CAR-T clinical trials led to clinical clinical hypersensitivity reactions due to quality problems during product preparation, and were repeatedly stopped by the FDA. Hypersensitivity reactions can be fatal if not addressed in time. With advances in technology, hypersensitivity is no longer the first safety consideration, and cytokines storm or cytokines release syndrome has risen to the number one safety risk. Cytokine release syndrome is a T cell-based activation that is a response to T cell activation activity, so side effects are clinically positively related to the therapeutic mechanism of CAR-T.

Currently, CAR-T cell therapy targeting CD-19 is reported in the treatment of ALL, CLL, and NHL, thanks to anti-IL-6 antibodies. In the first case of CAR-T, the sick child did not retreat. When the blood phase was checked, the IL-6 reached a hundred times normal value. Fortunately, the attending doctor thought of the anti-IL-6 antibody Tocilizumab (Actemra). After the antibody is used, high fever is controlled. If this patient died of high fever, I am afraid that CAR-T will not be able to go today.

It is well known that cytokine release syndrome is by far the most serious side effect of CAR-T treatment. During the administration of CAR-T, patients almost always occur, but to varying degrees, and the way they are handled is different. According to the CTCAE standard, grades 4-5 are extremely serious and fatal. So is there a quick test method to predict the severity of the symptoms in order to achieve effective prevention? Dr. David T Teachey from the Children's Hospital of Pennsylvania University found two prescribing biomarkers (Biomaker). Teachey analyzed the symptomatic grading of cytokine release syndrome and serum cytokine levels in 51 CAR-T-treated patients. Cytokine release syndrome occurred in 48 of 51 patients treated with CAR-T, mostly in moderate to low response. However, 14 patients developed severe cytokine release syndrome, and 21 patients received anti-IL-6 antibody therapy. Used to control high fever. A regression analysis found that two cytokines reached high peaks during the first three days of CAR-T treatment: one was interferon gamma (INFδ), and the other was a protein called Sgp-130, which is IL-6. Antagonists reflect the increase in IL-6 from the side. Dr. David T Teachey found through regression analysis that the signature features of the three cytokines were associated with cytokine release syndrome predictions, with a correlation of more than 96%. Dr. Teachey said that perhaps there is no best predictive method, but measuring several key cytokines within 48 hours is helpful for predicting and responding to severity. Simultaneous measurement of INFδ, IL-6, and sgp-130 outside the author should be simple and easy, and it is a dangerous prediction method for pre-visiting.

Researchers at the famous CAT-T cell therapy company Juno Therapeutics are also developing similar assays for predicting and preventing cytokine release syndrome. Today, as the FDA continues to raise the threshold for security, the ability to control security risks directly affects approval, and no one dares to take it lightly.

Source: US and Chinese medicine source

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