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.
Treatment: Universal Donor (UD) TGFβi NK Cells · Temozolomide · Irinotecan · Dinutuximab · GM-CSF — This is a phase II study looking at patient response to treatment with the combination dinutuximab, temozolomide, irinotecan, and GM-CSF.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Prior therapy
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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