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OncoMatch/Clinical Trials/NCT06450041

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

Is NCT06450041 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for neuroblastoma.

Phase 2RecruitingNew Approaches to Neuroblastoma Therapy ConsortiumNCT06450041Data as of May 2026

Treatment: Universal Donor (UD) TGFβi NK Cells · Temozolomide · Irinotecan · Dinutuximab · GM-CSFThis is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.

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Extracted eligibility criteria

Cancer type

Neuroblastoma

Prior therapy

Min 4 prior lines

Cannot have received: myelosuppressive chemotherapy

must not have received within 2 weeks prior to registration

Cannot have received: biologic anti-neoplastics (not associated with reduced platelet or ANC counts, including retinoids)

must not have received within 7 days prior to registration

Cannot have received: monoclonal antibody

Exception: resolution of all toxicities required

must not have received last dose within 14 days of registration and resolution of all toxicities

Cannot have received: cellular therapy (modified T cells, NK cells, dendritic cells)

Exception: resolution of all toxicities required

must not have received within 3 weeks and resolution of all toxicities

Cannot have received: radiation therapy

must not have received small port radiation within 7 days prior to registration, large field radiation within 12 weeks, and 131I-MIBG therapy or other radiopharmaceutical within 6 weeks

Cannot have received: hematopoietic stem cell transplant (myeloablative)

none following myeloblative therapy within 6 weeks

Cannot have received: investigational agent

Any other investigational agents (covered under another IND) within 14 days

Cannot have received: strong CYP3A4 inducer or inhibitor

Strong inducers or inhibitors of CYP3A4

Lab requirements

Blood counts

Absolute Neutrophil count ≥750/µL; Platelet count ≥ 75,000/µL, transfusion independent (no platelet transfusions within 7 days of blood draw documenting eligibility)

Kidney function

age-adjusted serum creatinine ≤1.5 ULN for age

Liver function

Total bilirubin ≤ 1.5 x ULN for age; SGPT (ALT) ≤ 135 U/L (≤ 3x ULN, ULN=45 U/L)

Cardiac function

Normal ejection fraction (≥ 55%) or normal fractional shortening (≥ 27%) documented by echocardiogram

Hematologic Function: ANC ≥750/µL, Platelets ≥ 75,000/µL, transfusion independent. Renal Function: age-adjusted serum creatinine ≤1.5 ULN for age. Liver Function: Total bilirubin ≤ 1.5 x ULN for age; SGPT (ALT) ≤ 135 U/L (≤ 3x ULN, ULN=45 U/L). Cardiac Function: Normal ejection fraction (≥ 55%) or normal fractional shortening (≥ 27%) documented by echocardiogram.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Children's Hospital Los Angeles · Los Angeles, California
  • UCSF Benioff Children's Hospital · San Francisco, California
  • Children's Hospital Colorado · Aurora, Colorado
  • Comer Children's Hospital, University of Chicago · Chicago, Illinois
  • Boston Children's Hospital, Dana-Farber Cancer Institute. · Boston, Massachusetts

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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