QUILT-3.033: Haplo NK With SQ ALT-803 for Adults With Relapsed or Refractory AML

Phase 2 Completed 8 enrolled Masonic Cancer Center, University of Minnesota

NaSingle-groupOpen-labelTreatment

Summary

This is a multi-institutional Simon's optimal two-stage phase II trial of CD3/CD19 depleted, ALT-803 activated, haploidentical donor NK cells and subcutaneous ALT-803 given after lymphodepleting chemotherapy (CY/FLU) for the treatment of refractory or released acute myelogenous leukemia (AML).

Timeline

Start: 2017-05-16
Primary completion: 2019-12-15
Completion: 2019-12-15

Publications

Berrien-Elliott MM, Becker-Hapak M, Cashen AF, Jacobs M, Wong P, Foster M, McClain E, Desai S, Pence P, Cooley S, Brunstein C, Gao F, Abboud CN, Uy GL, Westervelt P, Jacoby MA, Pusic I, Stockerl-Goldstein KE, Schroeder MA, DiPersio JF, Soon-Shiong P, Miller JS, Fehniger TA. Systemic IL-15 promotes allogeneic cell rejection in patients treated with natural killer cell adoptive therapy. Blood. 2022 Feb 24;139(8):1177-1183. doi: 10.1182/blood.2021011532.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Donor NK Cells	Cell therapy	—	—
Subject	N-803	Protein / enzyme biologic	10 ug/kg	Subcutaneous
Background	Cyclophosphamide	Other / unclassified	60 mg/kg	—
Background	Fludarabine	Small molecule	25 mg/m2	—

QUILT-3.033: Haplo NK With SQ ALT-803 for Adults With Relapsed or Refractory AML

Summary

Timeline

Publications

Drugs

Indications