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New treatment option for Neuroblastoma
Official title Haploidentical Donor Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Neuroblastoma
ClinicalTrials.gov ID: NCT07635056
What this study is testing
What is CIML-NK Cells?
CIML-NK Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 39
You may be able to join if
- 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...
- With relapsed or refractory disease, including at least one of the following:
- Recurrent disease at any time after completion of frontline therapy
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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...
- With relapsed or refractory disease, including at least one of the following:
- Recurrent disease at any time after completion of frontline therapy
- Progressive disease at any time following standard induction therapy
- Primary resistant or refractory disease defined by failure to achieve a complete response by International Neuroblastoma Response Criteria (INRC) after at least four cycles of standard, multidrug induction chemotherapy...
- Patients must have evaluable disease documented within four weeks of study enrollment. Evaluable disease must include at least one of the following:
- Measurable tumor (\>10 mm in at least one dimension) on MRI or CT scan that is either MIBG, FDG or 68Ga-DOTATATE avid
- One or more MIBG, FDG, or 68Ga-DOTATATE avid bone lesion
- Microscopic marrow metastasis based on routine morphology and/or immunohistochemistry in at least one sample from bilateral aspirates and biopsies at the time of study enrollment.
- With performance level of \>50% on Lansky (\ 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...
- With available haploidentical related donors.
- 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...
- Known allergy or hypersensitivity reaction to IL-2 injections
- Pregnant or breastfeeding women
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.