CAR T-cell therapy is an advanced treatment for blood cancers, in which T-cells, also known as T-lymphocytes, which are a type of white blood cell involved in the body’s immune response, are re-engineered to attack malignant cells. This is accomplished by modifying the CAR receptors on T-cell membranes so that they bind to antigens on the surface of cancer cells. CAR T-cell therapy is incredibly potent in that the engineered cells continue to divide and multiply in the body, meaning that even after a single treatment, effects can last for months or even years.
Sheba’s Hemato-Oncology Division, led by Prof. Arnon Nagler, carries out the entirety of CAR T-cell therapy onsite – one of the only cancer treatment facilities in the world to do so. Prof. Nagler, who has over 25 years of experience in the field and is a world-renowned expert in hemato-oncology, explains that “keeping the entire process at the medical center ensures the maximum quality of the cells. By eliminating extra steps and reducing the number of parties involved, therapy costs are also significantly reduced.”
At Sheba, the entire CAR T-cell therapy process is carried out in-house and takes just ten days from start to finish. When the cells are sent to an external laboratory for engineering, it can take several months. Such delay reduces the efficacy of CAR T-cell therapy by lowering the quality of the altered T-cells, which must be frozen and thawed. Furthermore, during the time it takes for the T-cells to be ready for reintroduction into the patient’s body, the disease continues to progress, making positive treatment outcomes harder to attain without using other supplementary cancer treatments, which can further weaken the patient’s condition.
However, CAR T-cell therapy involves a highly specialized clinical process, requiring treatment centers that provide complete treatment to invest in state-of-the-art facilities and extensive staff training. “The challenges of in-house therapy include the initial establishment of the program, monitoring quality assurance, completing the process of dry and wet rounds, and taking into account reproducibility. It may take a few months to achieve a stable process, at which point it needs to be approved by local and national authorities for regulation,” Prof. Nagler added.
According to Prof. Nagler, another crucial element to the establishment and function of new CAR T-cell programs is a national network to objectively select and approve patients for the therapy. Then, the production of genetically altered T-cells must be fine-tuned to meet the high demand for CAR T-cell therapy while, at the same time, maintaining a high standard of quality. Finally, laboratories producing T-cells must establish a strict QA system to ensure the best possible results for patients.
As demand for CAR T-cell therapy increases, more cancer treatment centers are planning to offer the treatment onsite, even though Prof. Nagler anticipates that it will be a few years until it becomes widely accessible.