Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342336
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-19
Brief Title:
HS-IT101 Injection in the Treatment of Advanced Solid Tumors
Sponsor:
Qingdao Sino-Cell Biomedicine Co Ltd
Organization:
Qingdao Sino-Cell Biomedicine Co Ltd
Study Overview
Official Title:
Single Arm Phase I Clinical Study of HS-IT101 Injection in the Treatment of Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Single-arm open-labelinterventional study evaluating adoptive cell therapy ACT with autologous tumor-infiltrating lymphocyte TIL infusion HS-IT101 after lymphodepletion preparative with fludarabine and cyclophosphamide regimen followed by IL-2 for the treatment of patients with advanced solid tumor
Detailed Description:
HS-IT101 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process for the treatment of patients with advanced solid tumor The cell transfer therapy used in this study involves patients receiving lymphodepletion treatment with fludarabine and cyclophosphamide followed by infusion of autologous TIL then finnaly followed by the administration of a regimen of IL-2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None