A Clinical Trial on Autologous NK Cells Combined With GD2 Monoclonal Antibody in the Treatment of Children With Newly Diagnosed High-risk or Relapsed/Refractory Neuroblastoma

Launched by GUANGZHOU WOMEN AND CHILDREN'S MEDICAL CENTER · Apr 22, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for children with a type of cancer called neuroblastoma, specifically for those who have either just been diagnosed with high-risk neuroblastoma or whose cancer has come back after treatment. The study will test a special kind of immune cell called autologous NK (natural killer) cells, combined with a medication known as GD2 monoclonal antibody, to see if this combination can safely improve the effectiveness of treatment. The trial aims to include 15 children aged 1 to 18 years who meet specific health criteria, such as having measurable cancer and normal organ function.

Participants in this trial can expect to receive the study treatment alongside standard chemotherapy. The researchers will closely monitor their health and any potential side effects to determine how well this new treatment works. It’s important for families to know that the trial is not yet open for recruitment, and they must provide informed consent before taking part. This means that patients and their guardians will receive all necessary information about the trial to make an informed decision.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 1-18 years (including 18 years), gender not restricted;
• • 2. Diagnosed with high-risk neuroblastoma and meeting the following conditions: high-risk neuroblastoma has undergone standardized treatment including induction therapy and consolidation therapy according to COG, SIOPEN or the expert consensus CCCG-NB-2021, and has entered the maintenance stage; high-risk neuroblastoma has undergone induction therapy with COG chemotherapy combined with GD2 immunotherapy and has entered the maintenance stage; any recurrence of high-risk neuroblastoma after standardized treatment; or the disease is initially determined to be in a refractory state.
• • 3. If it is relapsed/refractory neuroblastoma, there must be at least one measurable lesion according to RECIST 1.1 criteria;
• 4. Normal major organ function, that is, meeting the following standards:
• • (1) Blood routine test: hemoglobin \>= 80 g/L; absolute neutrophil count (ANC) \>=0.75×10\^9/L; platelet count \>= 75×10\^9/L; (2) Blood biochemistry test: serum albumin \>=28 g/L; total bilirubin \<= 2×upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT) \<= 3×ULN; alkaline phosphatase (ALP) \<= 3×ULN; creatinine \<= 1.5×ULN; (3) Coagulation function: international normalized ratio (INR) or prothrombin time (PT) \<= 1.5×ULN; activated partial thromboplastin time (APTT)\<=1.5×ULN; (4) Echocardiogram shows normal diastolic function of the heart, left ventricular ejection fraction (LVEF) \>= 50%, and no severe arrhythmia; (5) No severe lung or kidney disease, no active pulmonary infection. Indoor air oxygen saturation \>=92%; 5. Expected survival time \>= 6 months; 6. After obtaining full informed consent from the patient and guardian, sign the informed consent form.
• Exclusion Criteria:
• • 1. Uncontrollable active infections, or expected to receive systemic anti-infection or immunosuppressive therapy during participation in this trial;
• • 2. Any toxic reactions caused by previous anti-tumor treatments have not recovered to grade 1 or below (CTCAE 5.0 version) (hair loss is not restricted);
• • 3. Have a history of organ transplantation or are expected to undergo organ transplantation during the trial period;
• • 4. Highly allergic constitution;
• • 5. HIV infection;
• • 6. The researchers believe that there are other circumstances in which the subjects are not suitable to participate in this study.