OncoMatch/Clinical Trials/NCT04211675
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Is NCT04211675 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for relapsed neuroblastoma.
Treatment: Natural Killer Cells · Temozolomide · Irinotecan · Dinutuximab · Sargramostim — This is a Phase 1 study with Phase 2 expansion cohort. Phase 1 will assess the safety and tolerability of universal donor TGFβi NK Cell in combination with irinotecan, temozolomide, and dinituximab. The phase 2 of the study will estimate the response to treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Prior therapy
Must have received: frontline therapy (chemotherapy, radiation therapy, autologous stem cell transplantation, retinoids, immunotherapy with anti GD2 agents, cellular therapies, I-131 MIBG) — frontline
Patients must have progressed during or following completion of frontline therapy. Agents considered to be a part of frontline therapy would include chemotherapy, radiation therapy, autologous stem cell transplantation, retinoids, immunotherapy with anti GD2 agents, cellular therapies, or I-131 MIBG
Cannot have received: irinotecan (irinotecan)
Exception: allowed if not received within last 6 months
No treatment with irinotecan and/ or temozolomide within the last 6 months.
Cannot have received: temozolomide (temozolomide)
Exception: allowed if not received within last 6 months
No treatment with irinotecan and/ or temozolomide within the last 6 months.
Lab requirements
Blood counts
Peripheral absolute neutrophil count (ANC) ≥500/microL. Platelet count ≥50,000/microL (transfusion independent for at least 1 week)
Kidney function
Creatinine clearance or estimated radioisotope GFR ≥70 ml/min/1.73m2 or Serum creatinine < 2x upper limit of normal (ULN) based on age/gender
Liver function
Total bilirubin <1.5x ULN for age AND SGPT (ALT) ≤5x ULN for age (or ≤225 U/L). For purpose of this study, the ULN for SGPT (ALT) is 45 U/L.
Cardiac function
Shortening fraction of ≥ 27% by ECHO OR Ejection fraction ≥ 50% by ECHO or gated radionuclide study
Adequate bone marrow function, defined as: Peripheral absolute neutrophil count (ANC) ≥500/microL... Platelet count ≥50,000/microL... Adequate renal function defined as: Creatinine clearance or estimated radioisotope GFR ≥70 ml/min/1.73m2 or Serum creatinine < 2x upper limit of normal (ULN) based on age/gender... Adequate liver function defined as: Total bilirubin <1.5x ULN for age AND SGPT (ALT) ≤5x ULN for age (or ≤225 U/L)... Adequate cardiac function defined as: Shortening fraction of ≥ 27% by ECHO OR Ejection fraction ≥ 50% by ECHO or gated radionuclide study
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Nationwide Children's Hospital · Columbus, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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 qualify