Sylvester Comprehensive Cancer Center researchers in collaboration with Kite Pharma, are currently recruiting patients for a Phase 2 clinical trial testing investigational cancer immunotherapy drug KTE-C19 for the treatment of diffuse large B-cell lymphoma, the most common form non-Hodgkin’s lymphoma (NHL). The drug, designed with chimeric antigen receptor (CAR) T cell technology, is a novel cellular immunotherapy approach, being used for the first time by Sylvester to treat patients in South Florida.
The potential new immunotherapy treatment uses T cells taken from the patient and engineered by Kite Pharma to recognize and destroy tumor cells. After extraction from the blood and using a technique called gene transfer, researchers introduce potent receptors into the T cells allowing them to destroy malignant cells. The expanded T cells are sent to Sylvester and reintroduced into the patient’s circulation system and, ideally, travel to the tumor site and kill malignant cells.
The team used a genetic construct called chimeric antigen receptor (CAR), a synthetic receptor that is delivered and linked to specialized subsets of T cells by gene transfer. Once in circulation, the T cells are intended to specifically target and kill cancer cells that express certain proteins, such as CD19, found on the malignant B cells involved in most lymphomas.
The ZUMA-1 trial (NCT02348216) is a multicenter Phase 1/2 study to assess the safety and efficacy of KTE-C19 in patients with refractory, aggressive NHL, a type of blood cancer that has not responded to standard therapies. The KTE-C19 treatment involves three days of chemotherapy, a weeklong hospital stay, and up to 15 years of follow-ups and monitoring of disease response and remission. Moreover, the drug is also being evaluated for treatment of relapsed/refractory mantle cell lymphoma and relapsed/refractory B-precursor acute lymphoblastic leukemia, in the Zuma-2 clinical trial (NCT02601313) and ZUMA-3 trial (NCT02614066), respectively
“CAR-T cells represent a remarkable new way of harnessing the immune system and redirecting it to destroy cancer cells,” the study’s principal investigator Lazaros J. Lekakis, M.D., a hematologic oncologist at Sylvester, said in a news release. “In this trial, Kite Pharma, the sponsor of the study, genetically engineers the patient’s own T cells, an important component of the immune system, to recognize lymphoma cells and attack them in a way that mimics the way the immune system fights serious infections.”