OncoMatch/Clinical Trials/NCT04211675
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Is NCT04211675 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
Cancer type
Neuroblastoma
Demographics
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 →Frequently asked questions
Is NCT04211675 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior irinotecan, temozolomide disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 29 years or younger.
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