General Information |
| Summary |
To learn if the VGO-Cs01p can help to control CD7-positive relapsed/refractory acute T-lymphoblastic leukemia (R/R T-ALL) in children. |
| Description |
This is a single-arm, open label, IIT clinical trial to evaluate the safety and efficacy of CD7 CAR NK cells in subjects with CD7-positive relapsed/refractory acute T-lymphoblastic leukemia (R/R T-ALL). 5~9 subjects plan to be enrolled. In this study, safety and efficacy results will be used for dose escalation design at the same time, and three initial dose groups are set up. All subjects will be followed up to 12 months after infusion. |
| Clinical trials phase |
Early Phase 1 |
| Start date (estimated) |
2025-02-01 |
| End date (estimated) |
2026-10-31 |
| Clinical feature |
| Label |
childhood T-cell acute lymphoblastic leukemia |
| Link |
http://purl.obolibrary.org/obo/DOID_0080145 |
| Description |
A childhood acute lymphoblastic leukemia that has_material_basis_in T-cells. |
|
Administrative Information |
| NCT number |
NCT06849401 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06849401 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06849401 |
| Sponsors |
Shanghai Jiao Tong University School of Medicine
|
| Collaborators |
|
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 |
Not yet recruiting |
| Estimated number of participants |
9 |
