Project 466358

Patients with some forms of blood cancer that do not respond to standard therapies have a particularly poor chance of survival. Chimeric Antigen Receptor modified T cells (CAR-Ts) are a powerful new tool for treating these patients, with durable responses suggesting that these patients who respond are cured of their underlying cancer. CAR-T cells are made by isolating a patient's T lymphocytes (a type of white blood cell) from their blood, genetically modifying and activating the cells in the lab, and then re-administering them to the same patient, allowing for a patient's immune cells to be targeted against their tumour. Because CAR-T therapy is very personalized (requiring genetic engineering of the patient's own cells), there is considerable infrastructure and expertise required to manufacture and deliver this treatment safely and successfully. Currently, the pharmaceutical model for centralized manufacturing of CAR-T cells is not sustainable in Canada and has limited access to this potentially life-saving treatment. Our team has developed a program for domestic biomanufacturing of all of the components needed to make CAR-T cells, including a closed benchtop system for the final step of manufacturing, making the T cells. To provide this novel therapy to more Canadians across the country, this program needs to expand to other clinical and manufacturing sites. In the proposed clinical trial, we will treat adult patients with acute lymphoblastic leukemia with Canadian-made CAR-T cells across Canada at 6 clinical sites with 4 biomanufacturing sites, allowing us to cover all of the country for trial participation. We will be testing and analyzing the feasibility, safety and efficacy of our made-in-Canada CAR-T cells in these patients. This should provide the necessary information to approach Health Canada for clinical approval and bring this Canadian manufactured product to standard-of-care for Canadian cancer patients.