Haploidentical Donor Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Neuroblastoma

ConditionNeuroblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-39
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

The goal of this study is to demonstrate that cytokine-induced memory-like natural killer cells (CIML-NK cells) can be generated from donor cells and infused safely into patients with relapsed or refractory neuroblastoma during dinutuximab-based therapy.

Eligibility criteria

Qualifiers

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

Recurrent disease at any time after completion of frontline therapy

Disqualifiers

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

Trial design

Treatments tested in this trial

  • CIML-NK Cells

Treatment groups

20 Participants
are divided into 1 treatment group