NCT06450041 - NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 16, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2038

Conditions

Neuroblastoma

Interventions

DRUG

Universal Donor (UD) TGFβi NK Cells

Patients will receive a dose of 1x108 UD TGFβi NK cells/kg per treatment cycle on day 8 of each cycle

DRUG

Temozolomide

Enteral or IV daily on days 1-5 of each cycle For patients ≥ 0.5 m2: 100 mg/m2/dose For patients \< 0.5 m2: 3.3 mg/kg/dose MAXIMUM dose = 200 mg

DRUG

Irinotecan

50mg/m2/dose IV daily on days 1-5 of each cycle

DRUG

Dinutuximab

17.5mg/m2/dose IV daily on days 2-5 of each cycle

DRUG

GM-CSF

250mcg/m2/dose subcutaneous (preferred) or IV daily on days 6-12 of each cycle

Trial Locations (13)

38105

St. Jude Children's Research Hospital, Memphis

43205

Nationwide Children's Hospital, Columbus

48109

C.S Mott Children's Hospital, Ann Arbor

60614

Comer Children's Hospital, University of Chicago, Chicago

75235

University of Texas Southwestern, Dallas

76104

Cook Children's Medical Center, Fort Worth

80045

Children's Hospital Colorado, Aurora

94143

UCSF Benioff Children's Hospital, San Francisco

98105

Seattle Children's Hospital, Seattle

90027-0700

Children's Hospital Los Angeles, Los Angeles

02115

Boston Children's Hospital, Dana-Farber Cancer Institute., Boston

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

19104-4318

Children's Hospital of Philadelphia, Philadelphia