Using NK cells to treat high-risk neuroblastoma in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of systemic injections of allogenic natural killer (NK) cells in children aged 2 to 16 with refractory or recurrent high-risk neuroblastoma. The NK cells are sourced from healthy donors and undergo rigorous quality assessments before being administered to patients. Participants will receive a total of three injections, with the possibility of additional doses based on their response to treatment, and their progress will be monitored through imaging techniques. The study compares outcomes between those receiving NK cell therapy and a control group receiving standard treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. High-risk neuroblastoma that is resistant to standard induction therapy based on COG (Children's Oncology Group) criteria (according to INRG criteria and having received at least 4 cycles of multi-drug induction chemotherapy, and not responding to conventional treatments).
2. Evidence of relapse or progression of neuroblastoma after autologous peripheral blood stem cell transplantation or aggressive therapy.
3. A minimum life expectancy of 6 months.
4. Patients must have a pathological diagnosis of neuroblastoma and/or confirmation of tumor cells in the bone marrow with increased urinary catecholamines.
5. Measurable residual disease based on imaging findings using Curie scoring or MIBG or PET imaging criteria (1: measurable tumor of at least 10 mm in one dimension on MRI or CT scan with positive uptake on I-123 MIBG scan ("MIBG avid") oOR 2): increased FDG uptake on 18F-FDG PET-CT or PET-MRI ("PET avid")).

   \-

Exclusion Criteria:

1. Insufficient bone marrow function: Platelet count \> 50,000/µL, independent of transfusion (no platelet transfusion within one week). Absolute neutrophil count (ANC) maximum of 500 per microliter. Hemoglobin \> 10 grams per deciliter.
2. Insufficient liver function: Plasma bilirubin level more than 1.5 times the upper limit of normal (ULN). SGPT (ALT) at least three times the upper limit of normal (a level of 45 units per liter is considered the upper limit of normal).
3. Insufficient kidney function: Creatinine clearance or estimated radioisotope GFR \< 70 ml/min/1.73m². Plasma creatinine level more than 1.5 times the upper limit of normal based on age/gender.
4. Insufficient central nervous system function if seizures are present, entry into the study is not possible and if seizures are not well controlled with anticonvulsant drugs.

3- Insufficient cardiovascular function Shortening fraction \< 27% by ECHO OR Ejection fraction \< 50% by ECHO or gated radionuclide study.

4- Insufficient pulmonary function evidence of dyspnea at rest. Exercise intolerance. Chronic need for oxygen and room air pulse oximetry \< 94% if pulse oximetry evaluation is clinically indicated. Presence of current pleural or pericardial effusion.

5- Inability to tolerate new treatment due to emergency conditions. 6- Elevated catecholamines (more than twice the ULN) or sole involvement of bone marrow (bone marrow positive for NB as the only evaluable disease without confirmatory pathology report).

7- Receiving 0.5 mg/kg/day of systemic steroids (equivalent to prednisone) for at least 7 days before enrollment.

8- Receiving CYP3A4 inducers or inhibitors at least 7 days before study enrollment.

9- Diagnosis of any other malignancy alongside the diagnosis of neuroblastoma. 10- Diarrhea \> Grade 2 (4 to 6 stools per day). 11- Significant illness not covered by exclusion criteria but interfering with the study process or increasing the intensity of treatment with NK cells.

12- Participation in another clinical trial. 13- Severe impairment of major organ functions, such as renal, cardiac, hepatic, neurological, pulmonary, or gastrointestinal toxicity above Grade 2 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTC v5.0).

14- Inability to comply with protocol requirements. 15- Lack of confirmed and signed consent by the patient's guardians. 16- Evidence of HIV disease (Human Immunodeficiency Virus) or positive serology for HIV.

Where it's running

• Rasoul Akram Hospital
  Tehran, Iran Recruiting

Study contacts

• Principal investigator: Dr. Mohammad Faranoush, Pediatric Oncologist — Iran University of Medical Science
• Study coordinator: Dr. Marzieh Ebrahimi
• Email: m.ebrahimi@royan-rc.ac.ir
• Phone: +98 9123448359

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for relapsed or refractory neuroblastoma in children

  This trial tests a four-drug combination to see if it can control neuroblastoma in children whose disease has come back or not responded to treatment.

  Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07318831

• Targeted radiopharmaceutical radiotherapy for relapsed or refractory neuroblastoma

  A short, patient-friendly test of [211At]MABG radiotherapy to see if it is safe and tolerable in kids and young patients with relapsed or hard-to-treat neuroblastoma.

  Recruiting Early Phase 1 Sichuan University · Chengdu, Sichuan · NCT07767630

• Chemoimmunotherapy with autologous NK‑cell therapy for children with refractory or relapsed high‑risk neuroblastoma and ganglioneuroblastoma

  This treatment will test whether adding a child's own expanded natural killer (NK) cells to chemoimmunotherapy helps children with refractory or relapsed high‑risk neuroblastoma or ganglioneuroblastoma respond better.

  Recruiting Phase 3 Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Moscow · NCT07375563

• MIBG SPECT/CT and somatostatin receptor PET for diagnosing and staging neuroblastoma

  This study tests whether combining 123I‑MIBG SPECT/CT and somatostatin receptor PET improves detection, staging, and identification of PRRT candidates among children with suspected or confirmed neuroblastoma.

  Recruiting Nanjing First Hospital, Nanjing Medical University · Nanjing, Jiangsu · NCT07064746

• CAR-T cell therapy for relapsed neuroblastoma and desmoplastic small round cell tumors

  This study is testing a new CAR-T cell therapy to see if it can help people with relapsed neuroblastoma and desmoplastic small round cell tumors feel better and improve their chances of survival.

  Recruiting at 3 sites Phase 1/2 Sun Yat-sen University · Guangzhou, Guangdong and 2 other locations · NCT06836505

• Using engineered T-cells to treat relapsed or refractory neuroblastoma in children

  This study is testing a new type of engineered T-cell treatment for children with relapsed or hard-to-treat neuroblastoma to see if it can help fight their cancer.

  Recruiting at 2 sites Phase 1 Nanjing Children's Hospital · Nanjing, Jiangsu and 1 other locations · NCT06751134

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.