Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma

PHASE1CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

January 5, 2016

Primary Completion Date

July 28, 2025

Study Completion Date

July 28, 2025

Conditions
NeuroblastomaHigh-Risk
Interventions
DRUG

cyclophosphamide

chemotherapy with intravenous (IV) cyclophosphamide 50mg/kg/day (for patients with body weight\<70kg) or 1500mg/m\^2/day (for patients with body weight ≥70kg) for two days (days -6 and -5).

BIOLOGICAL

NK cells

Day 0: NK cell infusion. NK cells are resuspended in Normasol at a concentration no less than 5 x 10\^6cells/mL. The patient is pre-medicated as per standard cell product infusion. The cell product is infused through a central venous catheter. Patients will be evaluated clinically by vital signs pre- and approximately 30 minutes post infusion of NK cells and thereafter at approximately 1 hour intervals for 4 hours.

BIOLOGICAL

hu3F8

On Days -1, +1, +5, +7 and +9 hu3F8 is administered at 1.68 mg/kg/day and infused over \~30-90 minutes

DRUG

rIL-2

On day 0, daily from +2 through +4, day +6, and day +8, rIL-2 is administered subcutaneously at 6 x 10\^5 U/m\^2/day.

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Y-mAbs Therapeutics

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER