Biopharmaceutical company Kiadis and The Ohio State University (OSU) – Arthur G James Cancer Hospital and Richard J Solove Research Institute have launched a first-in-human clinical trial in patients with relapsed/refractory acute myeloid leukaemia (R/R AML) with off-the-shelf natural killer (NK) cells manufactured using Kiadis’ FC21 mbIL21 feeder cells and proprietary universal donor platform. The trial is expected to provide further clinical proof-of-concept of Kiadis’ K-NK003 product.
The investigator-sponsored trial will be conducted at OSUCCC – James, a National Cancer Institute (NCI)-designated comprehensive cancer centre and freestanding cancer hospital located in Columbus, Ohio, USA. The OSUCCC – James team received US Food and Drug Administration (FDA) approval for an investigational new drug application to begin and expects to enrol patients later this month.
Kiadis will support the study through a collaborative research agreement with OSUCCC-James. Additionally, OSU and Kiadis plan to work together to initiate a company-sponsored trial with off-the-shelf K-NK003 cells expanded with Kiadis’ particle production platform (PM21) in the same patient population later this year.
The study, entitled A Phase I Clinical Trial Testing the Safety of IL-21-Expanded, Off-the-shelf, Third-party Natural Killer Cells for the Induction of Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome, will evaluate the NK cell product in up to 56 patients, ages 18 – 80, who have primary refractory AML, relapsed AML, or myelodysplastic syndromes (MDS). The goal of this study is to establish the safety of the NK cell therapy for the induction of remission in patients with R/R AML or MDS and to determine the optimal dosing and overall response rate. Patients enrolled in the study will receive six doses of NK cells of 1 x 107 cells/kg to 1 x 108 cells/kg after receiving reinduction chemotherapy.