Haploidentical Donor Natural Killer Cell Infusion With IL-15 in Acute Myelogenous Leukemia (AML)

Phase 1 Completed 26 enrolled Masonic Cancer Center, University of Minnesota

NaSingle-groupOpen-labelTreatment

Summary

This is a single center, "modified standard design" dose escalation study designed to determine the maximum tolerated, minimum efficacious dose (MTD/MED) of IL-15 (Intravenous Recombinant Human IL-15) and incidence of donor natural killer (NK) cell expansion by day +14 when given after haploidentical donor NK cells in patients with relapse or refractory acute myelogenous leukemia (AML).

Timeline

Start: 2011-09
Primary completion: 2015-03
Completion: 2015-03

Publications

Cooley S, He F, Bachanova V, Vercellotti GM, DeFor TE, Curtsinger JM, Robertson P, Grzywacz B, Conlon KC, Waldmann TA, McKenna DH, Blazar BR, Weisdorf DJ, Miller JS. First-in-human trial of rhIL-15 and haploidentical natural killer cell therapy for advanced acute myeloid leukemia. Blood Adv. 2019 Jul 9;3(13):1970-1980. doi: 10.1182/bloodadvances.2018028332.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	N-803	Protein / enzyme biologic	0.25 ug/kg	Intravenous
Subject	N-803	Protein / enzyme biologic	0.5 ug/kg	Intravenous
Subject	N-803	Protein / enzyme biologic	0.75 ug/kg	Intravenous
Subject	N-803	Protein / enzyme biologic	1 ug/kg	Intravenous
Subject	N-803	Protein / enzyme biologic	2 ug/kg	Intravenous
Subject	N-803	Protein / enzyme biologic	3 ug/kg	Intravenous
Background	Cyclophosphamide	Other / unclassified	60 mg/kg	—
Background	Fludarabine	Small molecule	25 mg/m2	—

Haploidentical Donor Natural Killer Cell Infusion With IL-15 in Acute Myelogenous Leukemia (AML)

Summary

Timeline

Publications

Drugs

Indications