Kiadis announces first patient enrolled with off-the-shelf K-NK cells
Kiadis Pharma, a clinical stage biopharmaceutical company, and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital (OSUCCC-James), today announced that the first patient has been enrolled and treated in a phase I, first-in-human clinical trial in patients with relapsed/refractory acute myeloid leukemia (“R/R AML”) with off-the-shelf Natural Killer (“NK”) cells manufactured at the Cell Therapy laboratory at the OSUCCC-James using Kiadis’ FC21 and proprietary universal donor platforms. The trial is being conducted at the OSUCCC-James and is expected to provide valuable data to support Kiadis’ K-NK003 development program.
The phase I study, NCT04220684, 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 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. The trial is expected to provide further clinical proof-of-concept of Kiadis’ K-NK003 product. Kiadis is supporting the Investigator-sponsored study through a collaborative research agreement with OSUCCC-James.
Sumithira Vasu, MBBS, the principal investigator of the clinical trial, hematologist and scientist, Medical Director of the Cell Therapy Lab at OSUCCC-James, and associate professor at the Ohio State College of Medicine says,
“This off-the-shelf universal donor NK cell therapy is an exciting new experimental treatment option for patients with R/R AML and MDS that allows us to infuse large numbers of hyperfunctional NK cells immediately when needed. Treating our first patient with this therapy is an important step in this ongoing clinical research.”
Andrew Sandler, MD, chief medical officer of Kiadis commented,
“This trial uses a novel off-the-shelf, readily available NK cell product to treat a very sick and difficult-to-treat group of patients. We are very enthusiastic with the initiation of this trial and to be one step closer to bringing K-NK-cell therapies to a broad patient population across a potentially wide range of cancers.”
Source: Kiadis Pharma (press release)
