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

This is a prospective, single-arm, open, single-center clinical trial to evaluate the safety and efficacy of autologous NK cells combined with chemotherapy and GD2 monoclonal antibody in the treatment of newly diagnosed high-risk or relapsed/refractory neuroblastoma in children. Fifteen eligible subjects are planned to be included. The objective is to evaluate the safety and efficacy of autologous NK cells combined with GD2 monoclonal antibody in the treatment of children with newly diagnosed high-risk or relapsed/refractory neuroblastoma, which is expected to be safe and effective in improving PFS and DCR in children with refractory/recurrent neuroblastoma.

Study Overview

• Status: Not yet recruiting
• Conditions: Neuroblastoma; GD2 Antibody; Autologous NK Cell
• Intervention / Treatment: Combination product: autologous NK cell plus GD2 antibody

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Tianyou Yang; Phone Number: +86 159 2048 8379; Email: mdtianyouyang@hotmail.com
• Study Contact Backup: Name: Manna Zheng; Phone Number: +86 156 2621 2126; Email: zmn_gzm@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention arm; using autologous NK cells combined with GD2 monoclonal antibody	Combination product: autologous NK cell plus GD2 antibody; Combination of autologous NK cells and GD2 monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival	3 years
adverse event	during the treatment phase
serious adverse event	during the treatment phase
event-free survival	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
progression-free survival	3 years

Collaborators and Investigators

• Sponsor: Guangzhou Women and Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: neuroblastoma; GD2 antibody; autologous NK cell
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neuroblastoma; Immunologic Factors; Physiological Effects of Drugs; Antibodies
• Other Study ID Numbers: NK-GD2 neuroblastoma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No