NeuroblastomaPhase 1/2NCT06948994
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
A Phase 1/2 study testing autologous NK cell plus GD2 antibody in people with Neuroblastoma and GD2 Antibody, run by Guangzhou Women and Children's Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Neuroblastoma, GD2 Antibody, Autologous NK Cell
- What is being tested?
- autologous NK cell plus GD2 antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 30 Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 1-18 years (including 18 years), gender not restricted;
- 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.
- If it is relapsed/refractory neuroblastoma, there must be at least one measurable lesion according to RECIST 1.1 criteria;
- Normal major organ function, that is, meeting the following standards:
- 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.
Who cannot join
- Uncontrollable active infections, or expected to receive systemic anti-infection or immunosuppressive therapy during participation in this trial;
- 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);
- Have a history of organ transplantation or are expected to undergo organ transplantation during the trial period;
- Highly allergic constitution;
- HIV infection;
- The researchers believe that there are other circumstances in which the subjects are not suitable to participate in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Neuroblastoma, GD2 Antibody, Autologous NK Cell
- Being tested
- autologous NK cell plus GD2 antibody
- Keywords
- neuroblastoma, GD2 antibody, autologous NK cell
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous NK cell plus GD2 antibodyCombination product
Combination of autologous NK cells and GD2 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | using autologous NK cells combined with GD2 monoclonal antibody Receives: Combination Product: autologous NK cell plus GD2 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse event
Measured: during the treatment phase
serious adverse event
Measured: during the treatment phase
overall survival
Measured: 3 years
event-free survival
Measured: 3 years
Secondary outcomes (1)
progression-free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948994
- Sponsor's protocol ID
- NK-GD2 neuroblastoma
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06948994
- Acronym / sponsor ID
- NK-GD2 neuroblastoma
- Conditions
- Neuroblastoma, GD2 Antibody, Autologous NK Cell
- Keywords
- neuroblastoma, GD2 antibody, autologous NK cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Combination Product: autologous NK cell plus GD2 antibodyusing autologous NK cells combined with GD2 monoclonal antibody |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 1-18 years (including 18 years), gender not restricted;
- 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.
- If it is relapsed/refractory neuroblastoma, there must be at least one measurable lesion according to RECIST 1.1 criteria;
- Normal major organ function, that is, meeting the following standards:
- 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.
Key exclusion criteria (6 listed)
- Uncontrollable active infections, or expected to receive systemic anti-infection or immunosuppressive therapy during participation in this trial;
- 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);
- Have a history of organ transplantation or are expected to undergo organ transplantation during the trial period;
- Highly allergic constitution;
- HIV infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous NK cell plus GD2 antibodyCombination of autologous NK cells and GD2 monoclonal antibody | Combination product | intervention arm |
Primary outcome
adverse event
Time frame: during the treatment phase
serious adverse event
Time frame: during the treatment phase
overall survival
Time frame: 3 years
event-free survival
Time frame: 3 years
1 secondary outcome
progression-free survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing autologous NK cell plus GD2 antibody in people with Neuroblastoma and GD2 Antibody, run by Guangzhou Women and Children's Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianyou Yang (+86 159 2048 8379, mdtianyouyang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse event (time frame: during the treatment phase). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.