Actively Recruiting
Phase I/II Study of Universal Donor TGFb2i NK Cell Infusions with Irinotecan, Temozolomide, and Dinutuximab in Relapsed or Refractory Neuroblastoma
Led by Nationwide Children's Hospital · Updated on 2025-05-13
31
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of universal donor TGFb2i natural killer (NK) cells combined with irinotecan, temozolomide, and dinutuximab for patients with relapsed or refractory neuroblastoma. This Phase 1/2 clinical trial aims first to assess safety and tolerability in Phase 1, then to estimate treatment response in Phase 2. The study is sponsored by Nationwide Children's Hospital and focuses on a population under 30 years of age with verified neuroblastoma or related conditions. The treatment plan involves six cycles, each lasting 21 days. Each cycle includes irinotecan, temozolomide, dinutuximab, sargramostim, and NK cell infusions. NK cells are given at a dose of 1x10^8 cells per kg on day 8 of each cycle. Temozolomide and irinotecan are administered on days 1 to 5, dinutuximab on days 2 to 5, and sargramostim on days 6 to 12. Treatment cycles repeat every 21 days depending on disease response and side effects, with tumor response assessments after cycles 2, 4, and 6. Patients without significant toxicity and with disease control may continue therapy. Participants will undergo regular monitoring including CT or MRI scans, MIBG imaging, and bone marrow aspirations to evaluate response. Safety is closely tracked through adverse event reporting over 12 months and toxicity assessments up to 36 months. The study measures how patients tolerate the NK cell therapy and how their tumors respond to the combined treatment. The total participation duration may last up to two years, with ongoing evaluations throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Less than 30 years of age at study registration
- Histologic confirmation of neuroblastoma, ganglioneuroblastoma, or presence of neuroblastoma cells in bone marrow
- Life expectancy greater than 2 months
- Recurrent disease, or progressive disease during initial therapy, or primary resistant/refractory disease after at least 4 induction chemotherapy cycles
- Measurable or evaluable tumor by MRI, CT, MIBG scan, or PET within 4 weeks before study entry
- Disease represents recurrence, progression, or refractory status
- Patients with biopsy-proven viable neuroblastoma if tumors are not MIBG or PET avid
- Progression during or after frontline therapy including chemotherapy, radiation, stem cell transplant, immunotherapy, or cellular therapies
- No irinotecan or temozolomide treatment within last 6 months
- Adequate bone marrow function (ANC 500/microL, platelet count 50,000/microL transfusion independent)
- Adequate renal function (creatinine clearance 70 ml/min/1.73m2 or serum creatinine less than twice upper limit normal)
- Adequate liver function (bilirubin <1.5x ULN and ALT 5x ULN)
- Adequate CNS function (controlled seizures, CNS toxicity grade 2 or less)
- Adequate cardiac function (shortening fraction 27% or ejection fraction 50%)
- Adequate pulmonary function (no dyspnea at rest, no oxygen requirement, pulse oximetry >94% if indicated)
You will not qualify if you...
- Pregnancy or breastfeeding
- Elevated catecholamines greater than twice upper limit normal
- Use of systemic steroids at prednisone equivalent doses above 0.5 mg/kg/day within 7 days prior to enrollment
- Use of CYP3A4 inducers or inhibitors within 7 days prior to enrollment
- 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 that may interfere with study agents or increase toxicity severity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks (6 cycles of 21 days each)
Participants receive up to 6 cycles of treatment every 21 days. Each cycle includes irinotecan, temozolomide, dinutuximab, sargramostim, and natural killer (NK) cells infusions.
6 treatment cycles with multiple visits per cycle
Duration - Up to 36 months
Participants are monitored for safety, response to treatment, and long-term toxicities after completing treatment.
Visits for assessments at 12, 24, and 36 months
Trial Site Locations
Total: 1 location
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
M
Melinda Triplet, RN
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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