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

PHASE2CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

May 16, 2017

Primary Completion Date

December 15, 2019

Study Completion Date

December 15, 2019

Conditions
Acute Myeloid Leukemia
Interventions
BIOLOGICAL

ALT-803

"Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4~ALT-803 Stimulated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be stimulated by overnight incubation with 36.1 ng/mL ALT-803 under GMP conditions and infused on day 0.~ALT-803 to Facilitate NK Cell Survival and Expansion:~ALT-803 at 10 mcg/kg subcutaneously (SC) with the 1st dose administered on day 0 (no sooner than 4 hours post NK cells), day +5 and day +10 for 3 doses total"

Trial Locations (1)

55455

Masonic Cancer Center at University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT03050216 - QUILT-3.033: Haplo NK With SQ ALT-803 for Adults With Relapsed or Refractory AML | Biotech Hunter | Biotech Hunter