Donor 'Memory' immune cells take on childhood cancer
NCT ID NCT07635056
First seen Jun 25, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether specially trained donor immune cells, called CIML-NK cells, can be safely given to 20 children and young adults (ages 1-39) with relapsed or refractory neuroblastoma. The cells are made from a half-matched donor and infused alongside standard dinutuximab therapy. The main goal is to check for serious side effects, while also seeing if the treatment can shrink tumors or stabilize the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cytokine-Induced Memory-Like Natural Killer (CIML-NK) cells from a half-matched donor
- What this could lead to
- If it works, this could offer a new treatment option for children and young adults with neuroblastoma that has come back or not responded to standard therapy.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply to everyone. The cell therapy carries risks of infusion reactions and other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Dec 2026
An estimate. Start dates often move.
- Expected to finish
-
Jun 2031
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
1 year to 39 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 as high-risk disease * With relapsed or refractory disease, including at least one of the following: 1. Recurrent disease at any time after completion of frontline therapy 2. Progressive disease at any time following standard induction therapy 3. 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 on or according to a high-risk neuroblastoma protocol * Patients must have evaluable disease documented within four weeks of study enrollment. Evaluable disease must include at least one of the following: 1. Measurable tumor (\>10 mm in at least one dimension) on MRI or CT scan that is either MIBG, FDG or 68Ga-DOTATATE avid 2. One or more MIBG, FDG, or 68Ga-DOTATATE avid bone lesion 3. 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) 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 Criteria: * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Neuroblastoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Cincinnati Children's Hospital Medical Center
RECRUITINGCincinnati, Ohio, 45229, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a drug duo outsmart resistant tumors?
- Can a Two-Drug combo outsmart returning childhood cancers?
- Can a Two-Drug combo beat tough childhood cancers?
- A simple blood test may reveal hidden infertility risk in young cancer survivors
- Can a shorter chemo combo tame High-Risk neuroblastoma?
- Can a radioactive 'Smart Bomb' take down resistant childhood cancers?