NeuroblastomaPhase 1NCT06631391
Phase I Study of Umbilical Cord Blood Natural Killer (NK) Cell Therapy for Children With High-risk, R/R Neuroblastoma.
A Phase 1 study testing umbilical cord blood NK cells in people with Neuroblastoma, run by Sun Yat-sen University at 2 sites in China.
Trial summary
Neuroblastoma is the most common extracranial solid tumor, with more than half of the patients diagnosed at the metastatic stage, classified as high-risk. High-risk neuroblastoma has a poor prognosis and low survival rate. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- umbilical cord blood NK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2024to 30 Nov 2029
- Phase
- Phase 1
- 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 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All of the following criteria must be met in order to be eligible for this trial:
- Agree to participate in the trial and sign a written informed consent form;
- Age ≤18 years, gender not limited;
- Karnofsky (≥16 years old) or Lansky (<16 years old) physical status score (Appendix II) of at least 50;
- Patients diagnosed with high-risk, recurrent/refractory neuroblastoma in children according to clinical diagnostic criteria, who have undergone comprehensive treatment (surgery, chemotherapy, radiotherapy ± stem cell transplantation ± GD2 monoclonal antibody therapy);
- Expected survival period of at least 12 weeks;
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- The patient must have fully recovered from the acute toxic effects of all previous anticancer chemotherapy, such as recovery to grade I after bone marrow suppression;
- Bone marrow suppressive chemotherapy: At least 21 days after the last bone marrow suppressive chemotherapy (if nitrosoureas were used previously, then 42 days);
- Investigational drugs or anticancer therapies other than chemotherapy: Must not be used within 28 days before the planned start of NK cell immunotherapy. Full recovery from the clinically significant toxicity of that therapy must be confirmed;
- Hematopoietic growth factors: At least 14 days after the last dose of long-acting growth factors or 3 days after the last dose of short-acting growth factors;
- X-ray therapy (XRT): At least 14 days after local palliative XRT (small field port); if other substantial bone marrow (BM) irradiation is involved, including prior radioactive iodine metaiodobenzylguanidine (131I-MIBG) treatment, it must end at least 42 days ago;
- Stem cell infusion without total body irradiation (TBI): No active graft-versus-host disease, must have ended at least 56 days after transplantation or stem cell infusion;
- Laboratory tests during the screening period must meet the following conditions:
- Absolute neutrophil count (ANC) ≥1.0×10^9/L (if bone marrow involvement, then ANC ≥0.5×10^9/L)
- Platelet count (PLT) ≥75×10^9/L (if bone marrow involvement, then PLT ≥20×10^9/L)
- Bilirubin ≤1.5 times the upper limit of normal (ULN)
- Creatinine ≤1.5 times ULN (calculated using the standard Cockcroft-Gault formula)
- ALT/AST ≤3 times ULN (if there is liver metastasis, this can be relaxed to 5 times ULN)
- During the study period, able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits; parents/guardians of pediatric or adolescent participants are capable of understanding, consenting to, and signing the informed consent form (ICF) and applicable child assent forms before initiating any protocol-related procedures; with parental/guardian consent, the participant is capable of expressing their consent (when applicable).
Who cannot join
- Patients who meet any of the following criteria are not eligible for this trial:
- Symptomatic brain metastases (patients whose brain metastases have been treated and whose symptoms have been stable for more than two months prior to enrollment may be enrolled, but must be confirmed by cranial MRI, CT, or venography as having no symptoms of cerebral hemorrhage);
- Suffering from the following cardiovascular diseases: grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450 ms for males and ≥470 ms for females); according to the NYHA standard (Appendix Three), class III-IV heart failure, or echocardiography indicating left ventricular ejection fraction (LVEF) <50%;
- Having a history of interstitial lung disease or suffering from interstitial lung disease at the same time;
- Coagulation disorders (INR >1.5 or prothrombin time (PT) >ULN +4 seconds or APTT >1.5 ULN), with a tendency to bleed or currently receiving thrombolytic or anticoagulant therapy;
- Arterial/venous thromboembolic events occurring within 12 months before enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
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- Known hereditary or acquired bleeding and thrombosis tendencies (such as hemophilia patients, coagulation disorders, thrombocytopenia, splenomegaly, etc.);
- Long-term unhealed wounds or fractures (except pathological fractures caused by tumors);
- Receiving major surgery or experiencing severe traumatic injuries, fractures, or ulcers within 4 weeks before enrollment;
- Factors significantly affecting the absorption of oral medications, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
- Experiencing abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before enrollment;
- Routine urine tests showing proteinuria ≥ +, and confirmed 24-hour urine protein quantification ≥1.0 g;
- Symptomatic serosal effusions requiring symptomatic treatment (including pleural effusion, ascites, pericardial effusion); Note: Asymptomatic serosal effusions can be enrolled, symptomatic serosal effusions after active symptomatic treatment (anticancer drugs cannot be used for treating serosal effusions), judged by the investigator to meet the enrollment criteria can be enrolled;
- Active infections requiring antimicrobial treatment (e.g., needing antibacterial drugs, antiviral drugs, excluding chronic hepatitis B antiviral treatment, antifungal drug treatment);
- History of psychoactive substance abuse that cannot be quit or has mental disorders;
- Participated in other antitumor drug clinical trials within 4 weeks before enrollment;
- Receiving systemic hormone therapy or undergoing any form of immunosuppressive therapy within 2 weeks before the first administration;
- In the past 2 years, suffered from active autoimmune diseases requiring systemic treatment (such as using disease-modifying drugs, corticosteroids, or immunosuppressants); Note: Substitutive treatments (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) do not count as systemic treatment;
- Contraindications for IL-2 use;
- Suffering from active infections requiring intravenous systemic treatment;
- Vaccinated with live vaccines within one month before the first use of the study drug, seasonal influenza vaccination with inactivated virus vaccines is allowed, but intranasal attenuated live influenza vaccines are not allowed;
- Previous or concomitant other uncured malignancies, cured skin basal cell carcinoma, cervical carcinoma in situ, and superficial bladder cancer are excluded;
- Other conditions judged by the investigator that may affect the conduct of the clinical study and the determination of study results;
- Virological tests during the screening period show any of the following:
- HBsAg positive and HBV DNA exceeds the upper limit of normal
- Anti-HCV positive and HCV RNA positive
- HIV positive
- Undergone allogeneic tissue/organ transplantation;
- Poor compliance, unable to cooperate with the clinical study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yizhuo zhang, +81-020-87342459, zhangyzh@sysucc.org.cn
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Yizhuo zhang, 020-87342460, zhangyzh@sysucc.org.cn
About this study
Official title: Pilot Study of Umbilical Cord Blood Natural Killer (NK) Cell Therapy for Pediatric Neuroblastoma.
Neuroblastoma is the most common extracranial solid tumor, with more than half of the patients diagnosed at the metastatic stage, classified as high-risk. High-risk neuroblastoma has a poor prognosis and low survival rate. Despite treatment with induction, consolidation, and maintenance therapy including GD2 monoclonal antibody, the survival rate is only about 60%, and many patients still relapse, progress, and die.
NK cell therapy is an emerging immunotherapy that can effectively inhibit and kill tumor cells without significant adverse reactions, reducing the risk of tumor recurrence and metastasis, and improving patients' immunity and quality of life. Its safety has been widely recognized. Currently, clinical trials of NK cell infusion therapy for neuroblastoma patients are ongoing, and NK cell-based immunotherapy holds great clinical promise for neuroblastoma. We plan to conduct a phase I clinical trial on umbilical cord blood NK cell therapy in combination with other treatments (GD2 antibody, chemotherpay, etc) for high-risk, recurrent/refractory neuroblastoma in children to determine the maximum tolerated dose of umbilical cord blood NK cell therapy in these patients, thereby laying the foundation for future combination therapies and phase II and III clinical studies.
Read the detailed description
To improve the prognosis of high-risk, Recurrent/Refractory neuroblastoma, we conducted a prospective Phase I clinical trial. Patients with high-risk and Recurrent/Refractory neuroblastoma who had undergone multidisciplinary treatment received umbilical cord blood NK cell infusions. The safety and efficacy of umbilical cord blood NK cells in combination with other therapy (GD2 antibody, chemotherpay, etc) were evaluated.
- Conditions
- Neuroblastoma
- Being tested
- umbilical cord blood NK cells
- Keywords
- neuroblastoma, umbilical Cord blood NK cells
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord blood NK cellsBiological
This is a phase I prospective clinical trial, including phase Ia and phase Ib. Phase Ia include 3 dose levels, utilizing a 3+3 design principle, and each dose level will enroll at least 3 subjects. The recommended dose for phase Ia was used in phase Ib. Each patient receives two courses of umbilical cord blood NK cell therapy (a total of 8 infusions of umbilical cord blood NK cells) and other therapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with umbilical cord blood NK cells | Experimental | All subjects will receive Ex vivo Expanded and activated umbilical cord blood NK cells infusion. Receives: Biological: umbilical cord blood NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of umbilical cord blood natural killer cell injection in combination with other treatments of high-risk, recurrent/refractory neuroblastoma in children
According to the '3+3' design principle, the Maximum Tolerated Dose (MTD) is determined. Adverse events observed during the trial are graded according to the NCI CTCAE 5.0 criteria. Adverse events related to the drug (definitely related, probably related, or possibly related) occurring within 36 days after the first infusion of umbilical cord blood NK cells (during the first cycle) are considered as Dose-Limiting Toxicity (DLT). The definitions of DLT include:
(1) Hematological toxicity:
Grade 4 neutropenia lasting ≥7 days; Grade 4 thrombocytopenia lasting ≥7 days; (2) Grade 3/4 non-hematological toxicities (excluding nausea, vomiting, and alopecia); (3) Any toxicity leading to a delay in chemotherapy for more than 2 weeks.
Measured: One weeks after the first cycle (each cycle is 28 days)
Secondary outcomes (1)
overall response rate (ORR) after 2 courses of umbilical cord blood natural killer cell infusion
ORR was evaluated according to the International Neuroblastoma Response Criteria (INRC)
Measured: Two weeks after the second cycle (a total of 16 weeks after the strart of first umbilical cord blood natural killer cell infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Nov 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To evaluate the safety, tolerability and efficacy of umbilical cord blood natural killer cell injection in combination with other treatments (GD2 antibody, chemotherpay, etc) in high-risk, recurrent/refractory neuroblastoma in children
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhuo Zhang, Sun Yat-sen University
- Investigators
- Yizhuo Zhang, Principal investigator, SunYat Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631391
- Sponsor's protocol ID
- UCBNK01
- Status last verified
- Feb 2025
- First submitted
- 7 Oct 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Song M, Lan Y, Tan X, Wu L, Zhu J, Lu S, Sun F, Gao M, Huang J, Que Y, Zhang Y, Fang X, Li M, Mai Y, Wang J, Xiang T, Zhang Y. Umbilical cord blood natural killer cells improve anti-GD2 antibody efficacy in neuroblastoma: from mouse to human. Oncoimmunology. 2026 Dec 31;15(1):2679315. doi: 10.1080/2162402X.2026.2679315. Epub 2026 May 30.
PubMed 42216567
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Umbilical Cord Blood Natural Killer (NK) Cell Therapy for Pediatric Neuroblastoma.
- ClinicalTrials.gov ID
- NCT06631391
- Acronym / sponsor ID
- UCBNK01
- Conditions
- Neuroblastoma
- Keywords
- neuroblastoma, umbilical Cord blood NK cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 8 Oct 2024 (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.
Neuroblastoma is the most common extracranial solid tumor, with more than half of the patients diagnosed at the metastatic stage, classified as high-risk. High-risk neuroblastoma has a poor prognosis and low survival rate. Despite treatment with induction, consolidation, and maintenance therapy including GD2 monoclonal antibody, the survival rate is only about 60%, and many patients still relapse, progress, and die.
NK cell therapy is an emerging immunotherapy that can effectively inhibit and kill tumor cells without significant adverse reactions, reducing the risk of tumor recurrence and metastasis, and improving patients' immunity and quality of life. Its safety has been widely recognized. Currently, clinical trials of NK cell infusion therapy for neuroblastoma patients are ongoing, and NK cell-based immunotherapy holds great clinical promise for neuroblastoma. We plan to conduct a phase I clinical trial on umbilical cord blood NK cell therapy in combination with other treatments (GD2 antibody, chemotherpay, etc) for high-risk, recurrent/refractory neuroblastoma in children to determine the maximum tolerated dose of umbilical cord blood NK cell therapy in these patients, thereby laying the foundation for future combination therapies and phase II and III clinical studies.
Detailed description
To improve the prognosis of high-risk, Recurrent/Refractory neuroblastoma, we conducted a prospective Phase I clinical trial. Patients with high-risk and Recurrent/Refractory neuroblastoma who had undergone multidisciplinary treatment received umbilical cord blood NK cell infusions. The safety and efficacy of umbilical cord blood NK cells in combination with other therapy (GD2 antibody, chemotherpay, etc) were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To evaluate the safety, tolerability and efficacy of umbilical cord blood natural killer cell injection in combination with other treatments (GD2 antibody, chemotherpay, etc) in high-risk, recurrent/refractory neuroblastoma in children
| Arm | Type | Receives |
|---|---|---|
| Treatment with umbilical cord blood NK cells | Experimental | Biological: umbilical cord blood NK cellsAll subjects will receive Ex vivo Expanded and activated umbilical cord blood NK cells infusion. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- Agree to participate in the trial and sign a written informed consent form;
- Age ≤18 years, gender not limited;
- Karnofsky (≥16 years old) or Lansky (<16 years old) physical status score (Appendix II) of at least 50;
- Patients diagnosed with high-risk, recurrent/refractory neuroblastoma in children according to clinical diagnostic criteria, who have undergone comprehensive treatment (surgery, chemotherapy, radiotherapy ± stem cell transplantation ± GD2 monoclonal antibody therapy);
- Expected survival period of at least 12 weeks;
Key exclusion criteria (29 listed)
- Symptomatic brain metastases (patients whose brain metastases have been treated and whose symptoms have been stable for more than two months prior to enrollment may be enrolled, but must be confirmed by cranial MRI, CT, or venography as having no symptoms of cerebral hemorrhage);
- Suffering from the following cardiovascular diseases: grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450 ms for males and ≥470 ms for females); according to the NYHA standard (Appendix Three), class III-IV heart failure, or echocardiography indicating left ventricular ejection fraction (LVEF) <50%;
- Having a history of interstitial lung disease or suffering from interstitial lung disease at the same time;
- Coagulation disorders (INR >1.5 or prothrombin time (PT) >ULN +4 seconds or APTT >1.5 ULN), with a tendency to bleed or currently receiving thrombolytic or anticoagulant therapy;
- Arterial/venous thromboembolic events occurring within 12 months before enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
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 |
|---|---|---|
| umbilical cord blood NK cellsThis is a phase I prospective clinical trial, including phase Ia and phase Ib. Phase Ia include 3 dose levels, utilizing a 3+3 design principle, and each dose level will enroll at least 3 subjects. The recommended dose for phase Ia was used in phase Ib. Each patient receives two courses of umbilical cord blood NK cell therapy (a total of 8 infusions of umbilical cord blood NK cells) and other therapy. | Biological | Treatment with umbilical cord blood NK cells |
Primary outcome
To evaluate the safety and tolerability of umbilical cord blood natural killer cell injection in combination with other treatments of high-risk, recurrent/refractory neuroblastoma in children
Time frame: One weeks after the first cycle (each cycle is 28 days)
According to the '3+3' design principle, the Maximum Tolerated Dose (MTD) is determined. Adverse events observed during the trial are graded according to the NCI CTCAE 5.0 criteria. Adverse events related to the drug (definitely related, probably related, or possibly related) occurring within 36 days after the first infusion of umbilical cord blood NK cells (during the first cycle) are considered as Dose-Limiting Toxicity (DLT). The definitions of DLT include: (1) Hematological toxicity: Grade 4 neutropenia lasting ≥7 days; Grade 4 thrombocytopenia lasting ≥7 days; (2) Grade 3/4 non-hematological toxicities (excluding nausea, vomiting, and alopecia); (3) Any toxicity leading to a delay in chemotherapy for more than 2 weeks.
1 secondary outcome
overall response rate (ORR) after 2 courses of umbilical cord blood natural killer cell infusion
Time frame: Two weeks after the second cycle (a total of 16 weeks after the strart of first umbilical cord blood natural killer cell infusion)
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 20 Feb 2025.
- Derived from this study: PubMed 42216567Song M, Lan Y, Tan X, Wu L, Zhu J, Lu S, Sun F, Gao M, Huang J, Que Y, Zhang Y, Fang X, Li M, Mai Y, Wang J, Xiang T, Zhang Y. Umbilical cord blood natural killer cells improve anti-GD2 antibody efficacy in neuroblastoma: from mouse to human. Oncoimmunology. 2026 Dec 31;15(1):2679315. doi: 10.1080/2162402X.2026.2679315. Epub 2026 May 30.
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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.
Yizhuo Zhang principal investigator
SunYat Sen University Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing umbilical cord blood NK cells in people with Neuroblastoma, run by Sun Yat-sen University at 2 sites in China.
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 19 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
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 Yizhuo zhang (020-87342460, zhangyzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of umbilical cord blood natural killer cell injection in combination with other treatments of high-risk, recurrent/refractory neuroblastoma in children (time frame: One weeks after the first cycle (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06631391, which also lists 1 linked publication.
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 20 Feb 2025.