RecruitingPhase 2NCT06450041

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

Phase II Study of Ex-Vivo Expanded Allogeneic Universal Donor TGFβi NK Cell Infusions in Combination With Temozolomide, Irinotecan, Dinutuximab, and Sargramostim in Patients With Relapsed or Refractory Neuroblastoma The STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial


Sponsor

New Approaches to Neuroblastoma Therapy Consortium

Enrollment

62 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 1 YearMax Age: 31 Years

Plain Language Summary

Simplified for easier understanding

This Phase II trial tests a multi-step immunotherapy approach for children and young adults with high-risk neuroblastoma (an aggressive childhood cancer) that has relapsed or is not responding. The treatment combines chemotherapy drugs (temozolomide and irinotecan), natural killer (NK) immune cells, and an antibody targeting the GD2 protein on cancer cells. **You may be eligible if...** - You are between 1 and 31 years old - You have been diagnosed with high-risk neuroblastoma that has relapsed or is refractory to treatment - Your diagnosis was confirmed by biopsy or bone marrow findings combined with elevated urine markers **You may NOT be eligible if...** - You have not been classified as high-risk neuroblastoma - You have certain active infections or health conditions that prevent this treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUniversal 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

DRUGTemozolomide

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

DRUGIrinotecan

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

DRUGDinutuximab

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

DRUGGM-CSF

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


Locations(13)

Children's Hospital Los Angeles

Los Angeles, California, United States

UCSF Benioff Children's Hospital

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Comer Children's Hospital, University of Chicago

Chicago, Illinois, United States

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

Boston, Massachusetts, United States

C.S Mott Children's Hospital

Ann Arbor, Michigan, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

University of Texas Southwestern

Dallas, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06450041


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