Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

January 14, 2019

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Neuroblastoma
Interventions
DRUG

Dinutuximab

17.5 mg/m2/day of dinutuximab will be given for 4 consecutive days (days 1-4 of each course) via intravenous infusion over ten hours.

BIOLOGICAL

NK Cells

The designated dose of NK Cells will be infused on Day 5 by IV drip using a Y infusion set with a filter-less chamber. Cells should not be delivered at a rate faster than 10 ml/kg/hr (as determined by drip rate or syringe push rate), and should not take longer than one hour for total infusion time if possible.

DRUG

Lenalidomide

25 mg/m2/day of Lenalidomide will be given at Dose Level 4, once daily with or without food by mouth on days -6 through +14.

Trial Locations (11)

30322

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta

43205

Nationwide Children's Hospital, Columbus

48109

C.S Mott Children's Hospital, Ann Arbor

60637

University of Chicago Comer Children's Hospital, Chicago

76104

Cook Children's Healthcare System, Fort Worth

94115

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

98105

Seattle Children's Hospital, Seattle

90027-0700

Children's Hospital Los Angeles, Los Angeles

02115

Childrens Hospital Boston, Dana-Farber Cancer Institute., Boston

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

19104-4318

Children's Hospital of Philadelphia, Philadelphia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Nationwide Children's Hospital

OTHER

collaborator

United Therapeutics

INDUSTRY

lead

New Approaches to Neuroblastoma Therapy Consortium

OTHER

NCT02573896 - Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells | Biotech Hunter | Biotech Hunter