Neuroblastoma
Conditions
Interventions
Sponsors
Children's Hospital Affiliated to Nanjing Medical University
Eligibility
Sex/Gender
All
Age
1 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Patients with recurrent neuroblastoma: the confirmed child neuroblastoma recurred after remission by standard treatment. 2. Patients with refractory neuroblastoma: (1) The patients who did not reach remission after 2 courses of standard chemotherapy were initially treated; (2) The patients who relapsed within 6 months after CR1 were called early relapse; (3) The patients who relapsed 6 months after CR1 but failed to reach remission after standard chemotherapy (called late recurrence); (4) Relapse 2 times or more. 3. Patients with relapsed and refractory neuroblastoma can be enrolled in the group with gD2 + by immunohistochemistry (more than 50% of the tumor cells have at least 2 + and anti-gd2-mab 14G2a). 4. Patients aged from 1 to 14 years old, both male and female. 5. Patients with good physical condition: ECoG score 0-2. 6. Patients weighing more than 15kg. 7. Patients with normal peripheral blood picture (i.e. white blood cell >= 4.0x10^9/l, hemoglobin > 100g / L, platelet count >= 50x10^9 / L) are generally required (see the text for details) 8. Patients with no obvious abnormality of heart, liver and kidney function (i.e. ECG is basically normal; renal function: Cr <= 2.0 x ULN (upper limit of normal value); liver function: alanine aminotransferase / aspartate aminotransferase <= 2.5 x ULN, bil <= 2.0 x ULN), no unhealed major trauma. 9. The patients who voluntarily participate in the study have good compliance, can cooperate with the observation of the trial, and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with various types of neuroblastoma lacking gD2 + expression. 2. Patients with organ failure; such as heart: Grade III and IV; liver: Grade C of child liver function classification; kidney: renal failure and uremia; lung: severe respiratory failure symptoms; brain: disturbance of consciousness. 3. Patients with severe and uncontrollable acute infection, or patients with suppurative and chronic infection, and delayed wound healing. 4. Patients with history of organ transplantation or obvious graft versus host disease (GVHD) after allogeneic hematopoietic stem cell transplantation. 5. Patients with systemic autoimmune disease or immunodeficiency disease or allergic constitution. Patients with abnormal coagulation function and severe thrombosis. 7 patients who have participated in other clinical trials in the past 30 days or participated in other clinical trials at the same time. 8. The researcher thinks that patients should not participate in other situations of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAR-T cells;PFS;OS; | — |
Countries
China
Contacts
Public ContactYongjun Fang
Children's Hospital Affiliated to Nanjing Medical University
Outcome results
None listed