Neuroblastoma
Conditions
Interventions
First dose group:Umbilical cord blood natural killer cells, 0.33×10^7/kg/time/person, with the first four administrations given once a week and the last four administrations given once every two weeks
Second dose group:Umbilical cord blood natural killer cells, 0.99×10^7/kg/time/person, with the first four administrations given once a week and the last four administrations given once every two week
The third dose group:Umbilical cord blood natural killer cells, 3.3×10^7/kg/time/person, with the first four administrations given once a week and the last four administrations given once every two we
Dose Expansion Cohort:Umbilical cord blood natural killer cells, the optimal dose determined in Phase Ia was used, with the first four administrations given once a week and the last four administratio
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Agree to participate in the experiment and sign a written informed consent form 2. Age = 16 years old) or Lansky (= 1.0 × 10^9/L (if there is bone marrow invasion, ANC >= 0.5 × 10^9/L); (2) Platelet count (PLT) >= 75 × 10^9/L (if bone marrow invasion, PLT >= 20 × 10^9/L); (3) Bilirubin <= 1.5 times ULN; (4) Creatinine <= 1.5 times ULN (calculated according to the standard Cockcroft Gault formula); (5) ALT/AST <= 3 times ULN (if there is liver metastasis, it can be relaxed to 5 times ULN) 13. During the participation in the study, be able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits; Parents/guardians of child or adolescent subjects have the ability to understand, agree, and sign the Research Informed Consent Form (ICF) and applicable Child Consent Form before initiating any protocol related procedures; With the consent of parents/guardians, subjects have the ability to express their consent (when applicable)
Exclusion criteria
Exclusion criteria: 1. Symptomatic brain metastases (patients with brain metastases who have completed treatment 21 days before enrollment and have stable symptoms for more than 2 months can be enrolled, but need to be confirmed to have no symptoms of cerebral hemorrhage through cranial MRI, CT or venography evaluation) 2. Suffering from the following cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval >= 450 ms for males and >= 470 ms for females); According to NYHA standards (Appendix III), patients with grade III-IV cardiac dysfunction or those with left ventricular ejection fraction (LVEF)1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy 5. Arterial/venous thrombotic events that occurred within the 12 months prior to enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism 6. Known genetic or acquired bleeding and thrombophilia tendencies (such as in hemophilia patients, coagulation dysfunction, thrombocytopenia, splenic hyperfunction, etc.) 7. Long term untreated wounds or fractures (excluding pathological fractures caused by tumors) 8. Having undergone major surgical procedures or suffered from severe traumatic injuries, fractures, or ulcers within the past 4 weeks of enrollment 9. Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction 10. Within the 6 months prior to enrollment, there has been an abdominal fistula, gastrointestinal perforation, or abdominal abscess 11. Urine routine test indicates urinary protein >=++ and confirms 24-hour urinary protein level >= 1.0 g 12. Serous fluid accumulation (including pleural effusion, ascites, and pericardial effusion) with clinical symptoms that require symptomatic treatment; Note: Asymptomatic serous fluid accumulation can be included in the study, while symptomatic serous fluid accumulation can be treated with active symptomatic treatment (anticancer drugs cannot be used for serous fluid treatment). Those who meet the inclusion criteria determined by the researcher can be included in the study 13. Active infections that require antimicrobial treatment (such as the use of antibacterial and antiviral drugs, excluding chronic hepatitis B anti-hepatitis B treatment and antifungal drug treatment); 14. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders 15. Those who have participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment 16. Within 2 weeks prior to the first administration, the individual was receiving systemic hormone therapy or any other form of immunosuppressive therapy 17. Having an active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants) within the past 2 years; Note: Alternative therapies (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic therapies 18. Individuals with cont
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-Limiting Toxicity (DLT);Maximum Tolerated Dose (MTD);Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Pharmacodynamic (PD) and Biomarker Levels Before and After Administration;Spectrum, Phenotype, and Function of Umbilical Cord Blood NK Cells in Peripheral Blood and/or Bone Marrow;Disease Control Rate (DCR);Duration of Response (DOR);Event-Free Survival (EFS);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactZhang Yizhuo
Sun Yat-sen University Cancer Center
Outcome results
None listed