Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions in Children and Young Adults With High Risk Acute Myeloid Leukemia Receiving Myeloablative HLA-Haploidentical Hematopoietic Cell Transplant

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 24, 2021

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2028

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions

Peripheral blood (PB) ≤ 450 mL and based on donor weight (minimum 10 ml/kg) will be drawn from the HLA-haploidentical donor at least 16 days before the scheduled day of transplant (Day 0). HaploNK cells will be manufactured from the PB of the donor after co-culture with irradiated feeder cells (IFC) as described in Section 2.4. The recipients will receive three NK cell infusions on Day-1, Day+7 (± 1 day) and Day+42 (up to Day+90) from day of transplant (Day 0).

Trial Locations (13)

10595

New York Medical College, Valhalla

32803

AdventHealth Orlando, Orlando

33701

Johns Hopkins All Children's Hospital, St. Petersburg

43205

Nationwide Children's Hospital, Columbus

44195

Cleveland Clinic Lerner College of Medicine, Cleveland

53226

Medical College of Wisconsin, Milwaukee

60611

Ann & Robert H. Lurie Children's Hospital, Chicago

63110

Washington University, St. Louis, St Louis

80045

Children's Hospital Colorado, Aurora

84112

University of Utah, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

90027

Children's Hospital Los Angeles, Los Angeles

95109

Fred Hutchinson Cancer Center, Seattle

All Listed Sponsors
collaborator

Nationwide Children's Hospital

OTHER

collaborator

Seattle Children's Hospital

OTHER

lead

Michael Pulsipher

OTHER