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

Part of paid clinical trials in Los Angeles, California.

Sponsor
New Approaches to Neuroblastoma Therapy Consortium
Study ID
NCT06450041
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 31 Years
Healthy Volunteers
Not accepted

Interventions

  • Universal Donor (UD) TGFβi NK Cells — DRUG
    Patients will receive a dose of 1x108 UD TGFβi NK cells/kg per treatment cycle on day 8 of each cycle
  • Temozolomide — DRUG
    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
  • Irinotecan — DRUG
    50mg/m2/dose IV daily on days 1-5 of each cycle
  • Dinutuximab — DRUG
    17.5mg/m2/dose IV daily on days 2-5 of each cycle
  • GM-CSF — DRUG
    250mcg/m2/dose subcutaneous (preferred) or IV daily on days 6-12 of each cycle

Study Details

This is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.

Key Dates

Start date
Dec 16, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2038

Study Design

Enrollment
62 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Patients will be treated with chemoimmunotherapy (temozolomide, irinotecan, GM-CSF, and dinutuximab) plus UD TGFβi NK cells.

Primary Outcome Measure

Best Overall Response Rate of Evaluable Patients [ Time Frame: Baseline assessments from within 28 days before Day 1 on study and between days 12-24 of cycles 2, 4, and 6, and within two weeks after the last date of protocol therapy. Each cycle will be 21 days but may be extended to 28 days due to treatment delays. ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-0700
Araz Marachelian, MD
UCSF Benioff Children's HospitalSan FranciscoCalifornia94143
Kieuhoa Vo, MD
Children's Hospital ColoradoAuroraColorado80045
Margaret Macy, MD
Comer Children's Hospital, University of ChicagoChicagoIllinois60614
Ami Desai, MD
[email protected]
Boston Children's Hospital, Dana-Farber Cancer Institute.BostonMassachusetts02115
Suzanne Shusterman, MD
C.S Mott Children's HospitalAnn ArborMichigan48109
Rajen Mody, MD
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-3039
Katherine Sommers, MD
Nationwide Children's HospitalColumbusOhio43205
Keri Streby, MD
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-4318
Yael Mosse, MD
St. Jude Children's Research HospitalMemphisTennessee38105
Sara Federico, MD
University of Texas SouthwesternDallasTexas75235
Tanya Watt, MD
Cook Children's Medical CenterFort WorthTexas76104
Chelsee Greer, DO
Seattle Children's HospitalSeattleWashington98105
Mark Fluchel, MD

Find similar trials in Los Angeles, CA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Children's Hospital Los Angeles· Los Angeles, CAUCSF Benioff Children's Hospital· San Francisco, CAChildren's Hospital Colorado· Aurora, COComer Children's Hospital, University of Chicago· Chicago, ILBoston Children's Hospital, Dana-Farber Cancer Institute.· Boston, MAC.S Mott Children's Hospital· Ann Arbor, MI

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