Results from a phase 1/2A trial at the University of Texas MD Anderson Cancer Center show that treatment with cord blood-derived chimeric antigen receptor (CAR) natural killer (NK)-cell therapy targeting CD19 resulted in clinical responses in a majority of patients with relapsed or refractory non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL), with no major toxicities observed. 

CAR NK cells are allogenic, which is defined as taking the cells from a non-related healthy donor rather than the patient themselves. Therefore, CAR NK cells have the potential to be manufactured in advance and stored for off-the-shelf immediate use. 

In contrast, currently commerically available CAR T cells require the use of a patient's own genetically modified T cells, created through a multi-week manufacturing process. 

The CD19 CAR NK cells used in this study were designed to target B-cell malignancies. 
 


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The study analyzed 11 patients who received a single dose of cord blood-dervied CD19 CAR NK cells, administered at 1 of 3 dose levels in 5 patients with CLL and 6 with NHL. All patients were treated with a minimum of 3 and maximum of 11 lines of prior therapy.

The first 9 patients received CD19 CAR NK cells that were partially matched according to the individual's human leukocyte anitgen type. However, the protocol allowed the final 2 patients to be treated with no HLA matching. 

Eight of the 11 patients responded to the therapy and 7 of those achieved a complete response, meaning they no longer showed evidence of disease at a median follow up of 13.8 months. Post-remission therapy was administered to 5 of the responding patients, none of whom experienced cytokine release syndrome or neurotoxicity. 

Adverse effects (AEs) reported by the participants were primarily related to the conditioning chemotherapy given before cell infusion and were resolved within 1 to 2 weeks, according to the study authors. No patients were required to be admitted to an intensive care unit for management of treatment AEs. 

REFERENCE

CD19 CAR NK-cell therapy achieves 73% response rate in patients with leukemia and lymphoma. The University of Texas- MD Anderson Cancer Center. https://www.mdanderson.org/newsroom/cd19-car-nk-cell-therapy-achieves-73-percent-response-rate-in-patients-with-leukemia-and-lymphoma.h00-159379578.html. Published February 5, 2020. Accessed February 10, 2020.