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 (Jun 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
Treatments studied
Chemotherapy
Other
Cancer type
Neuroblastoma
Demographics
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 →Frequently asked questions
Is NCT06450041 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior myelosuppressive chemotherapy, biologic anti-neoplastics (not associated with reduced platelet or ANC counts, including retinoids), monoclonal antibody disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 31 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages