General AML

The FDA grants FATE-NK100 Investigational New Drug Application clearance for treatment of R/R AML

On 13th March 2017, the U.S. Food and Drug Administration (FDA) granted Investigational New Drug (IND) application clearance for FATE-NK100, a first-in-class adaptive Natural Killer (NK) cell, for the treatment of patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML).1

FATE-NK100 is comprised of a highly specialized and functionally distinct subset of NK cells expressing the memory-like activating receptor NKG2C and the maturation marker CD57. In AML, NK cells have been shown to exert powerful anti-leukemic activity in preventing relapse.2 Preclinical data have demonstrated that FATE-NK100 can induce a robust formation of adaptive memory NK cells which have an enhanced anti-tumor activity and improved persistence. Additionally, FATE-NK100 have been shown to stimulate an endogenous T-cell response and also resist immune checkpoints. 1,3

The IND approval granted by the FDA allows FATE-NK100 to be evaluated in a first-in-human trial in R/R AML patients. This study will evaluate the safety and determine the maximum dose of intravenous infusion of FATE-NK100 in R/R patients. Additionally, Complete Response (CR), Disease Free Survival (DFS), and clearance of Minimal Residual Disease (MRD) would also be accessed secondarily. Enrollment into trials are anticipated to start at the Masonic Cancer Center, University of Minnesota, following approval of the Center’s institutional review board.1

  1. GlobeNewswire: Fate Therapeutics Announces FDA Clearance of Investigational New Drug Application for FATE-NK100 Natural Killer Cell Cancer Immunotherapy. 2017 Mar 13. [Accessed 2017 Mar 14].
  2. Suck al. Natural Killer Cells for Therapy of Leukemia. Transfus Med Hemother. 2016 Mar; 43(2): 89–95. DOI: 1159/000445325.
  3. Cichocki F. et al. Development and Scale-up of a Novel GMP Method for Enrichment and Expansion of Terminally Differentiated Adaptive Natural Killer Cells (FATE-NK100) with Enhanced Anti-Tumor Function. 2016 December 5; Oral Abstract #1225: ASH 58th Annual Meeting and Exposition, San Diego, CA.
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