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This is a pilot phase I study to evaluate the safety and efficacy of NKG2D CAR-T cell therapy in patients with relapsed and/or refractory glioblastoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UWN2D CAR-T | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKG2D CAR-T | Biological | The NKG2D CAR-T will be administrated via intracerebroventricular injection through an Ommaya catheter. Standard treatments such as temozolomide will be stopped during the infusion of NKG2D CAR-T. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who experience a Dose-Limiting Toxicity (DLT) | Defined as the dose safely administered Intratumoral for the treatment of patients with GBM | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Defined as the proportion of subjects with overall response of either complete response (CR) or partial response (PR) | 1 year |
| Progression-free survival | Defined as date of the first NKG2D CAR-T infusion to the date of disease progression per RANO Response Criteria or death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng-Yi Kuo, PhD | Contact | +886-2-26972200 | 202 | jerry.kuo@uwell.com.tw |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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|
| 1 year |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |