Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613152
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
HS-IT201 Injection in the Treatment of Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study on the Safety and Efficacy of HS-IT201 Injection in the Treatment of Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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-IT201 after lymphodepletion preparative with fludarabine and cyclophosphamide regimen followed by IL-2 for the treatment of patients with advanced solid tumor
Detailed Description:
HS-IT201 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None