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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention arm | Experimental | using autologous NK cells combined with GD2 monoclonal antibody |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous NK cell plus GD2 antibody | Combination Product | Combination of autologous NK cells and GD2 monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse event | during the treatment phase | |
| serious adverse event | during the treatment phase | |
| overall survival | 3 years | |
| event-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 3 years |
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Inclusion Criteria:
(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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianyou Yang | Contact | +86 159 2048 8379 | mdtianyouyang@hotmail.com | |
| Manna Zheng | Contact | +86 156 2621 2126 | zmn_gzm@163.com |
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| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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