Malignant gliomas (MG) are highly aggressive tumors with 5-year survival rates historically less than 10%. Despite aggressive standard of care therapy with surgery, radiation, and chemotherapy, it is almost inevitable that the disease will relapse, and patients will ultimately succumb to their disease. Patients who relapse have few treatment options; thus, there is an unmet need for more effective treatment options and to improve outcomes. It was found that IL-13R is a protein that is highly abundant in MG. The investigators in this phase I study will utilize CAR T-cells targeting IL-13R in combination with an immune checkpoint inhibitor, nivolumab. CAR T-cell therapy is when a patient’s own T-cells (white blood cells that kill cancer cells) are collected via blood draw, then engineered to target specific cancer cells, multiplied, and infused back into the patient. IL-13R CAR T-cell therapy was found to be safe as a single agent in a previous City of Hope study funded by Gateway. Furthermore, a patient with MG in that study had a complete response. Nivolumab will work in a synergistic manner with the CAR T-cells, blocking cancer cells’ ability to evade from immune cells and potentially enhance the CAR T-cell therapy.
Trial Registration: ClinicalTrials.gov Identifier: NCT04003649