Actively Recruiting
Phase I Study of Umbilical Cord Blood Natural Killer (NK) Cell Therapy for Children With High-risk, R/R Neuroblastoma.
Led by Sun Yat-sen University · Updated on 2025-02-20
30
Participants Needed
2
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase I Study of Umbilical Cord Blood Natural Killer (NK) Cell Therapy for Children With High-risk, R/R Neuroblastoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to participate and sign a written informed consent form
- Age 18 years or younger, any gender
- Karnofsky score (if 16 years or older) or Lansky score (if younger than 16) of at least 50
- Diagnosed with high-risk, recurrent or refractory neuroblastoma after comprehensive treatment including surgery, chemotherapy, radiotherapy, stem cell transplantation, and GD2 monoclonal antibody therapy
- Expected survival of at least 12 weeks
- Fully recovered from acute toxic effects of previous cancer therapies
- At least 21 days since last bone marrow suppressive chemotherapy (42 days if nitrosoureas used)
- No investigational or anticancer therapies other than chemotherapy within 28 days before NK cell therapy start
- At least 14 days since last local palliative X-ray therapy or 42 days for substantial bone marrow irradiation
- Stem cell transplantation without total body irradiation ended at least 56 days ago and no active graft-versus-host disease
- Laboratory test results within specified safe limits for blood counts, liver and kidney function
- Able to comply with outpatient treatment, monitoring, and clinical visits
- Parents or guardians capable of understanding and consenting to the study processes
You will not qualify if you...
- Symptomatic brain metastases unless stable and symptom-free for over two months
- Certain cardiovascular diseases including class III-IV heart failure or poorly controlled arrhythmias
- History or presence of interstitial lung disease
- Coagulation disorders with active bleeding risk or on blood thinning therapy
- Recent arterial or venous blood clots within 12 months
- Known bleeding or thrombosis disorders
- Long-term unhealed wounds or fractures (except tumor-related fractures)
- Major surgery or severe injuries within 4 weeks
- Conditions affecting oral medication absorption
- Abdominal fistula, gastrointestinal perforation, or abscess within 6 months
- Significant proteinuria confirmed by urine tests
- Symptomatic serosal fluid buildup requiring treatment
- Active infections needing antimicrobial treatment
- History of substance abuse or mental disorders
- Participation in other cancer drug trials within 4 weeks
- Recent systemic hormone or immunosuppressive therapy within 2 weeks
- Active autoimmune disease needing systemic treatment within 2 years
- Contraindications for IL-2 use
- Active infections requiring IV systemic treatment
- Live vaccine within 1 month before study drug use
- Other active or uncured cancers except some skin or cervical cancers
- Conditions affecting study conduct or results as judged by investigator
- Positive viral tests for HBV, HCV, or HIV
- Previous allogeneic tissue or organ transplantation
- Poor compliance or inability to cooperate with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, China
Not Yet Recruiting
Research Team
Y
Yizhuo zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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