Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869539
Status:
RECRUITING
Last Update Posted:
2023-07-21
First Post:
2023-05-11
Brief Title:
ACT-TIL and ANV419 for Advanced Melanoma
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
A Phase I Trial of Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes and ANV419 in Patients With Advanced Melanoma The BaseTIL-03M Trial
Status:
RECRUITING
Status Verified Date:
2023-07
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:
BaseTIL-03M
Brief Summary:
In this study we aim to investigate safety and tolerability of tumor-infiltrating lymphocytes TIL adoptive cell therapy ACT incorporation in-vivo TIL expansion with ANV419 in patients with advanced melanoma
Detailed Description:
In brief this trial consists of four study periods screening pre-treatment treatment and observational follow-up
In the screening period patients are screened for trial eligibility In the pre-treatment period patients have excisional biopsysurgical resection of tumor lesions tumor collection and TILs are expanded from this lesionthese lesions TIL expansion Patients are permitted to receive bridging therapy outside of the study protocol
In the treatment period patients have TIL-ACT TIL-ACT includes a detailed procedure of preparative chemotherapy followed by transfer of the TIL product followed by in-vivo TIL expansion with ANV419 2 doses TIL transfer is defined as day 0 in the study protocol Patients have an End of Treatment visit 14 days after the last study treatment a safety follow-up 30 days after the last study treatment and an efficacy follow up which is the End of Study visit day 90
Thereafter patients will transfer to observational follow-up which is conducted every 3 months until 1 year after TIL transfer
Patients who terminate the study prematurely during any of the treatment period due to eg disease progression toxicity patient wish etc will also transfer to observational follow-up
The regimen TIL-ACT with ANV419 has not been tested Review by the IDSMB independent data safety monitoring board will be performed after 3 patients safety check
In the screening period patients are screened for trial eligibility In the pre-treatment period patients have excisional biopsysurgical resection of tumor lesions tumor collection and TILs are expanded from this lesionthese lesions TIL expansion Patients are permitted to receive bridging therapy outside of the study protocol
In the treatment period patients have TIL-ACT TIL-ACT includes a detailed procedure of preparative chemotherapy followed by transfer of the TIL product followed by in-vivo TIL expansion with ANV419 2 doses TIL transfer is defined as day 0 in the study protocol Patients have an End of Treatment visit 14 days after the last study treatment a safety follow-up 30 days after the last study treatment and an efficacy follow up which is the End of Study visit day 90
Thereafter patients will transfer to observational follow-up which is conducted every 3 months until 1 year after TIL transfer
Patients who terminate the study prematurely during any of the treatment period due to eg disease progression toxicity patient wish etc will also transfer to observational follow-up
The regimen TIL-ACT with ANV419 has not been tested Review by the IDSMB independent data safety monitoring board will be performed after 3 patients safety check
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