Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Yake Biotechnology Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Neuroblastoma (NB) is a malignant tumor of the sympathetic nervous system.Chemotherapy and autologous hematopoietic stem cell transplantation are the main treatments for neuroblastoma, and the prognosis of patients with high-risk recurrence and refractory treatment is very poor. There is a large unmet medical need in patients with relapsed refractory neuroblastoma, and further research into new therapeutic approaches is needed for these patients.GD2 is a dissialic ganglioside expressed by neuroectodermal tumors. The proportion of GD2 expression in neuroblastoma is up to 100%, so GD2 is a specific target for neuroblastoma immunotherapy and an ideal target for CAR-T treatment of neuroblastoma.
The subjects received the target dose of GD2-CAR-T from 1×106 to 1×108 /kg. Each subject will start with a low dose of 1×106/kg and if there are no significant side effects will be increased to the next dose until the maximum tolerated dose is reached. A variety of adverse events (including neurological events, hematological events, infections, and secondary tumors) will be collected from the time of infusion of CAR T cells to 24 months after infusion. To understand the complete response rate (CR) and partial response rate (PR) at 3 months; Recurrence rate, progression-free survival (PFS) and overall survival (OS) after 1 to 5 years of GD2-CAR-T reinfusion; The amount and duration of GD2-CAR-T in vivo.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | GD2 positive relapsed or refractory neuroblastoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GD2-CAR-T cell | Biological | Split intravenous infusion of GD2-CAR-T cells [dose escalating infusion of (1-100)x10^6 GD2-CAR-T cells/kg] |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Adverse events are evaluated with CTCAE V4.03 | 24 months |
| Overall response rate (ORR) | ORR includes CR, PR,MR.SD,PD.Complete response (CR)#All components CR.Partial response (PR)#PR in at least one component and all other components CR,minimal disease (bone marrow), PR or not involved at baseline.Minor response (MR)#PR or CR in at least one component but at least one other component with SD; no component with PD.Stable disease (SD)#SD in one component with no better than SD or not involved at baseline in any other component, no component with PD.Progressive disease (PD)#Any component with PD. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of overall response (DOR) | Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up. | 24 months |
| Progression-free survival(PFS) |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of CAR T-cells in vivo | The time of CAR-T cells' persistence in blood and the copies of CAR-T cells | 24 months |
| CAR-T related cytokine expression | CAR-T related cytokine expression. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JunXia Wang, Ph.D | Contact | 0086-28-86571605 | lzwjxyy@163.com | |
| Hai Yi, Ph.D | Contact | 0086-28-86571279 | yihaimail@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hai Yi, Ph.D | The General Hospital of Western Theater Command | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of Western Theater Command | Recruiting | Chengdu | Sichuan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
PFS will be assessed from the CAR-T cell infusion to progression, death or last follow-up.
| 24 months |
| Overall survival(OS) | OS will be assessed from the CAR-T cell infusion to death or last follow-up. | 24 months |
| 24 months |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |