Reference Detail

Ref Type

PMID

Authors

Sant P. Chawla, Katherine M Kim, Victoria S. Chua, Omid Jafari, and Paul Y. Song

Title

Phase I study of SNK01 (autologous non-genetically modified natural killer cells with enhanced cytotoxicity) in refractory metastatic solid tumors.

Journal	Vol	Issue	Date	Pages	Journal Short Title
			2020

URL

https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.e15024

Abstract Text

Background: Natural Killer (NK) cells possess the innate ability to detect transformed cancer cells and kill them, thus playing a key role in cancer immunosurveillance and antitumor immunity. In general, prior NK cell therapies have not shown efficacy in solid tumors and the expansion of NK cells in cancer patients to clinically therapeutic doses is quite challenging, making allogenic preferable to autologous treatment. SNK01 is a first-in-kind, autologous non-genetically modified NK cell therapy with enhanced cytotoxicity which can be consistently produced even from heavily pretreated cancer patients, and has been shown to have efficacy against numerous solid tumor types in preclinical studies. Methods: In this single-arm Phase I study (NCT03941262) to investigate the safety and efficacy of SNK01, patients with refractory metastatic solid tumors were treated in a 3 + 3 dose escalation study with five weekly infusions of SNK01 at 1, 2, or 4 x 109 cells per infusion. Primary endpoint is safety and quality of life (QoL), and secondary endpoint is objective response rate (ORR). Results: Seven of nine planned patients have been enrolled up to date and five have completed treatment. All patients have rapidly progressive metastatic disease and have received an average of five lines of prior therapy. Tumor types include one non-small lung cancer, one colorectal cancer, and five sarcomas. Median age is 52 (32-62). All patients have had successful expansion and cytotoxic enhancement of their NK cells. Three patients have completed 1 x 109 SNK01 and two patients have completed 2 x 109 SNK01. There have been no adverse events according to NCI-CTCAE v 5.0 or any cytokine release syndrome, and all patients have reported an overall improvement in QoL. At week 9, three of three patients at the 1 x 109 dose and one of two at the 2 x 109 achieved a best overall response of stable disease as per RECIST 1.1. Conclusions: Expanding and increasing the cytotoxicity of NK cells in our heavily pretreated patients has been consistently reliable. SNK01 monotherapy has been very safe and well tolerated in patients with rapidly progressive solid tumors. MTD has not been reached and dose escalation is ongoing. Evaluation of anti-tumor activity is ongoing, but at a minimum, SNK01 appears to slow and possibly halt progression in very aggressive disease and improve quality of life while improving the overall quality of life. The remaining two planned patients are currently being enrolled and a full update will be presented. Clinical trial information: NCT03941262.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials
SNK01	SNK01	0	1

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
SNK01		SNK-01\|SNK 01		SNK01 is a modified autologous natural killer cell therapy, which potentially increases cytotoxicity against tumor cells (J. of Clin. Onc. 2020 38:15_suppl, e15024).

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References