Actively Recruiting
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Led by Nationwide Children's Hospital · Updated on 2025-05-13
31
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Younger than 30 years of age at study registration
- Histologic confirmation of neuroblastoma, ganglioneuroblastoma, or neuroblastoma cells in bone marrow
- Life expectancy greater than 2 months and having recurrent, progressive, or refractory disease as defined
- Measurable or evaluable tumor by MRI/CT or positive uptake on MIBG or PET scans within 4 weeks prior to study entry
- Disease must be recurrent, progressive, or refractory after prior therapy
- Progression during or after frontline therapy which may include chemotherapy, radiation, stem cell transplant, retinoids, immunotherapy, cellular therapies, or I-131 MIBG
- No irinotecan or temozolomide treatment within the last 6 months
- Adequate bone marrow function with ANC 60500/microL and platelet count 6050,000/microL, without recent myeloid growth factors
- Adequate kidney function with creatinine clearance 6070 ml/min/1.73m2 or serum creatinine less than twice the upper limit of normal
- Adequate liver function with total bilirubin less than 1.5 times upper limit of normal and ALT less than 5 times upper limit
- Adequate central nervous system function with controlled seizures and no more than Grade 2 CNS toxicity
- Adequate heart function with shortening fraction 6527% or ejection fraction 6550%
- Adequate lung function without dyspnea at rest or oxygen requirement and normal pulse oximetry if indicated
You will not qualify if you...
- Pregnancy or breastfeeding
- Elevated catecholamines more than twice the upper limit of normal alone
- Systemic steroids at doses of 0.5 mg/kg/day prednisone equivalent within 7 days prior to enrollment
- Use of CYP3A4 inducers or inhibitors within 7 days prior to study start
- Diagnosis of any other malignancy
- Diarrhea greater than Grade 2
- Uncontrolled infection
- History of Grade 4 allergic reactions to anti-GD2 antibodies or reactions requiring stopping anti-GD2 therapy
- Significant illness interfering with study treatments or increasing toxicity risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
M
Melinda Triplet, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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