OncoMatch/Clinical Trials/NCT06631391
Phase I Study of Umbilical Cord Blood Natural Killer (NK) Cell Therapy for Children With High-risk, R/R Neuroblastoma.
Is NCT06631391 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies umbilical cord blood NK cells for neuroblastoma.
Treatment: umbilical cord blood NK cells — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Prior therapy
Must have received: comprehensive treatment (surgery, chemotherapy, radiotherapy, stem cell transplantation, GD2 monoclonal antibody therapy)
who have undergone comprehensive treatment (surgery, chemotherapy, radiotherapy ± stem cell transplantation ± GD2 monoclonal antibody therapy)
Cannot have received: investigational drugs or anticancer therapies other than chemotherapy
Must not be used within 28 days before the planned start of NK cell immunotherapy
Cannot have received: 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
Cannot have received: 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
Cannot have received: stem cell infusion without total body irradiation (TBI)
must have ended at least 56 days after transplantation or stem cell infusion
Cannot have received: major surgery or severe traumatic injuries, fractures, or ulcers
Receiving major surgery or experiencing severe traumatic injuries, fractures, or ulcers within 4 weeks before enrollment
Cannot have received: other antitumor drug clinical trials
Participated in other antitumor drug clinical trials within 4 weeks before enrollment
Lab requirements
Blood counts
ANC ≥1.0×10^9/L (≥0.5×10^9/L if bone marrow involvement); Platelet count ≥75×10^9/L (≥20×10^9/L if bone marrow involvement)
Kidney function
Creatinine ≤1.5x ULN (Cockcroft-Gault formula)
Liver function
Bilirubin ≤1.5x ULN; ALT/AST ≤3x ULN (≤5x ULN if liver metastasis)
Cardiac function
No grade II or higher myocardial ischemia/infarction, poorly controlled arrhythmias (QTc ≥450 ms for males, ≥470 ms for females), NYHA class III-IV heart failure, or LVEF <50%
Laboratory tests during the screening period must meet the following conditions: ... Bilirubin ≤1.5x ULN ... Creatinine ≤1.5x ULN ... ALT/AST ≤3x ULN (if there is liver metastasis, this can be relaxed to 5x ULN) ... 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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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