General Information |
| Summary |
The main objective of this clinical study is to evaluate the safety of XS005 cell which contains Natural Killer (NK) cells and culture-expanded injection; to determine the maximum tolerated dose . Furthermore, initial efficacy will be examined. |
| Description |
Treatment on this study includes eight XS005 cell infusions over an 16 week period. The study will evaluate the safety, feasibility and maximum tolerated dose (MTD) of XS005 cell using a 3+3 study design . The total study duration will be 2 years. |
| Clinical trials phase |
Phases 1/2 |
| Start date (estimated) |
2023-10-29 |
| End date (estimated) |
2025-12-29 |
| Clinical feature |
| Label |
glioblastoma |
| Link |
http://purl.obolibrary.org/obo/DOID_3068 |
| Description |
A malignant astrocytoma characterized by the presence of small areas of necrotizing tissue that is surrounded by anaplastic cells as well as the presence of hyperplastic blood vessels, and that has_material_basis_in abnormally proliferating cells derives_from multiple cell types including astrocytes and oligondroctyes. |
|
Administrative Information |
| NCT number |
NCT06147505 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06147505 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06147505 |
| Sponsors |
Dushu Lake Hospital Affiliated to Soochow University
|
Cells |
| Which differentiated cell type is used |
| Label |
natural killer cell |
| Link |
http://purl.obolibrary.org/obo/CL_0000623 |
| Description |
A lymphocyte that can spontaneously kill a variety of target cells without prior antigenic activation via germline encoded activation receptors and also regulate immune responses via cytokine release and direct contact with other cells. |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
30 |
