NCT07635056
Haploidentical Donor Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Neuroblastoma
Recruiting
PHASE2Ages 1–39InterventionalTreatmentChildren's Hospital Medical Center, CincinnatiInvestigator-initiated
~20 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:CIML-NK Cells
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Infusional Toxicity
Measured over 30 days
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Christopher Dandoy, MD, MS · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age 1-39 years at the time of study enrollment
With diagnosis of neuroblastoma with histologic verification
Classified as high-risk neuroblastoma as defined by Children's Oncology Group (COG) risk classification, including patients initially classified as low or intermediate risk at diagnosis with subsequent reclassification as high-risk disease
With relapsed or refractory disease, including at least one of the following:
Patients must have evaluable disease documented within four weeks of study enrollment. Evaluable disease must include at least one of the following:
With performance level of \>50% on Lansky (\<16 years) or Karnofsky (\>16 years) scales. Patients who are wheelchair bound due to paralysis will be considered ambulatory when assessing their performance score.
Adequate baseline cardiac and pulmonary function including a left ventricular ejection fraction (LVEF) \>50% by echocardiogram and pulse oximetry \>92% on room air documented within four weeks of study enrollment.
Adequate baseline hematologic function: peripheral absolute neutrophil count (ANC) ≥500/µL, with no receipt of long-acting myeloid growth factors within 14 days or short-acting myeloid growth factors within 7 days of study entry, and a platelet count ≥50,000/µL, with patients required to be transfusion independent for at least 7 days, unless cytopenias are related to marrow metastasis as defined above.
With available haploidentical related donors.
Exclusion
Infectious disease: Active, uncontrolled infection or received a live vaccine within 30 days prior to study enrollment.
Cardiac function: LVEF \<50% by echocardiogram, serious uncontrolled cardiac arrhythmias, or history of myocarditis or congestive heart failure (New York Heart Association Functional Classification III or IV)
Pulmonary function: Active interstitial lung disease (ILD)/pneumonitis or history of ILD/pneumonitis requiring systemic corticosteroid treatment.
Renal function: Glomerular Function Rate (GFR) \<50 mL/min/1.73 m2 as measured by cystatin C or NM GFR
Hepatic function: Total bilirubin \>5 mg/dL, AST and ALT \>10 times the upper limit of normal
Concomitant medications: receiving \>0.5 mg/kg prednisone equivalent daily
Receipt of any concomitant investigational treatments within 30 days at the time of the infusion of the IP. These investigational treatments include drugs, biologics, or devices that are still under investigation in clinical trials or research settings. The use of such agents may confound study results or pose additional safety risks
Known allergy or hypersensitivity reaction to IL-2 injections
Pregnant or breastfeeding women
What this trial measures
- Infusional Toxicity30 days
Number of subjects who receive an infusion of cytokine-induced memory-like natural killer cells (CIML-NK cells) without grade 3-4 infusional toxicity events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 divided by the number of patients enrolled.