Spots Global Cancer Trial Database for Open Label NK Cell Infusion (FATE-NK100) With Subq IL-2 in Adults With AML
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Trial Identification
Brief Title: Open Label NK Cell Infusion (FATE-NK100) With Subq IL-2 in Adults With AML
Official Title: Open Label Dose Escalation Trial of an Adaptive Natural Killer (NK) Cell Infusion (FATE-NK100) With Subcutaneous IL-2 in Adults With Refractory or Relapsed Acute Myelogenous Leukemia (AML)
Study ID: NCT03081780
Interventions
Study Description
Brief Summary: This is a Phase I open-label dose escalation study of a single infusion of FATE-NK100 and a short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting chemotherapy (CY/FLU) in subjects with refractory or relapsed acute myelogenous leukemia (AML). FATE-NK100 is a natural killer (NK) cell product that is enriched for NK cells with an "adaptive", or human cytomegalovirus (CMV)-induced, phenotype. The NK cell product is comprised of peripheral blood (PB) leukocytes sourced from a related donor (HLA-haploidentical or better but not fully HLA-matched) that is seropositive for cytomegalovirus (CMV+), and enriched for adaptive NK cells by depletion of CD3+ (T-lymphocytes) and CD19+ (B-lymphocytes) cells followed by ex-vivo culture expansion.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Minnesota, Masonic Cancer Center, Minneapolis, Minnesota, United States
Contact Details
Name: Murali Janakiram, MD, MS
Affiliation: University of Minnesota
Role: PRINCIPAL_INVESTIGATOR
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