ORLANDO, Fla. (Ivanhoe Newswire) — In 2017, the FDA approved the first CAR T-cell therapy. Medical experts call it a ‘breakthrough’ and ‘gamechanger’ when it comes to cancer treatment. Now, it’s issuing a warning.
Frederick Locke, MD, Dir., Immune Cell Therapy Program at Moffitt Cancer Center says, “Immunotherapy has really come on as quite an advance in cancer care.”
CAR T-cell therapy is a type of cellular immunotherapy used for patients with certain types of leukemias and lymphomas, as well as multiple myeloma. It uses the patient’s own immune system cells to attack cancer cells.
Doctor Locke says, “The blood comes out. It goes through a machine that removes the T-cells that we are interested in, and the blood is returned to the patient.”
The T-cells are then sent to a lab to be engineered into car T-cells. After a few weeks, they are returned to the patient’s bloodstream, where they can find and destroy the cancerous cells.
“We are actually taking the cells out and reprogramming them to get the strongest response possible from these chimeric antigen receptor T-cells, or CAR T-cells.” explains Doctor Locke.
Studies show positive response rates with CAR T-cell therapy, with many patients entering remission, and survival rates going up.
But now the FDA is investigating reports of T-cell cancers in people who had the treatment… with outcomes including hospitalizations and death. The FDA is instructing the manufacturers of these therapies to add a boxed warning – its highest safety-related warning. It says patients and clinical trial participants should also be monitored for new cancers.
Despite the warning, the FDA says it has no concern about continued use of this therapy, saying “The overall benefits of these products continue to outweigh their potential risks for their approved uses.”
As of the end of 2023, more than 27 thousand people in the US have received the CAR T-cell therapy. The FDA says it has received about 22 reports of cancers following the treatment.
Contributors to this news report include: Lindsay Dailey, Producer; Bob Walko, Editor.
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10835665/
https://www.mayoclinic.org/about-mayo-clinic/medical-innovation/kharfan-blood-cancer
https://www.youtube.com/watch?v=jt3CNgsCXAk
CAR T-CELL THERAPY: DO THE BENEFITS OUTWEIGH THE RISKS?
REPORT #3180
BACKGROUND: Car T-cell therapy is known as a treatment for blood cancers. It is a therapy that uses the body’s own immune system to fight cancer cells. Leukemia, lymphoma, and multiple myeloma are the most common cancers that use this therapy. T-cells are altered genetically in a lab and then used to locate and destroy cancer cells in the body. The therapy usually takes a few weeks but can take place in an outpatient setting. The first step is to collect the T-cells. This is done by drawing blood, then the blood goes into a machine that removes the T-cells, then returns the blood back to your body. The next step is engineering the T-cells. This is done in a lab where they add a manufactured CAR, then allow it to grow. The last step is infusing the Car T-cell where they inject the cells back into the arm.
BENEFITS AND RISKS: Car T-cell therapy is usually used as a last resort treatment. However, it is known to have positively helped people with blood cancer when other treatments have not. As with any form of therapy, there are risks. The first possibility is the treatment not working or not killing all of the cancer cells. Another risk is cancer relapse. This depends on other factors like the type of cancer and the patient’s overall health. Research has shown that B-cell lymphoma tends to resurface after Car T-cell therapy. Side effects are a risk, like fever, fatigue, nausea, diarrhea, and weakness. Some side effects can be very serious like rapid heart rate, low blood pressure, delirium, and kidney failure. Finally, lack of data is a risk. This therapy was first approved in 2017 and still has more research to be done and answers to be collected. In fact, in November 2023, the FDA started investigating the risk of T-cell malignancy following CAR T-cell immunotherapies and in January 2024 manufacturers were notified to include a boxed warning of this danger.
(Source: https://www.healthline.com/health/car-t-cell-therapy#benefits)
PROMISING TARGET FOR CAR T-CELL THERAPY: Researchers out of UCLA have identified the protein TYRP1 as a potential target for CAR T-cell immunotherapy. This new immunotherapy is designed to treat patients with rare subtypes of melanoma. The team found these engineered CAR T-cells effectively eliminated cancer cells in preclinical tests without causing severe side effects. “While TYRP1 has previously been targeted in clinical trials using monoclonal antibodies, this new approach harnesses the power of CAR T-cell therapy and has led to very good anti-tumor responses, improving the treatment’s overall effectiveness,” said Cristina Puig-Saus, PhD, assistant professor of medicine at the David Geffen School of Medicine at UCLA. The team developed a CAR model that targeted cells with elevated TYRP1. Then, they tested the newly engineered CAR T-cell in different types of melanomas. The result was the CAR T-cells completely eradicated cancer cells in both cell lines and animal models.
(Source: https://www.uclahealth.org/news/promising-target-car-t-cell-therapy-leads-potent-antitumor)
* For More Information, Contact:
Frederick Locke, MD
Moffit Cancer Center
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