Ignite Creation Date:
2024-05-06 @ 6:11 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05576077
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2022-10-07
Brief Title:
A Study of TBio-4101 TIL and Pembrolizumab in Patients With Advanced Solid Tumors
Sponsor:
Turnstone Biologics Corp
Organization:
Turnstone Biologics Corp
Study Overview
Official Title:
A Phase 1b Study of TBio-4101 Autologous Selected and Expanded Tumor-Infiltrating Lymphocytes TIL and Pembrolizumab in Patients With Advanced Solid Tumor Malignancies STARLING
Status:
RECRUITING
Status Verified Date:
2024-07
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:
STARLING
Brief Summary:
A multicenter trial to investigate TBio-4101 an autologous neoantigen-selected tumor-reactive TIL product in patients with advanced solid malignancies
Detailed Description:
This is a Phase 1 study to investigate TBio-4101 TBio-4101 is an autologous tumor infiltrating lymphocyte TIL therapy that utilizes tumor specific antigens to select sort and expand patient-specific tumor-reactive T-cells to be reinfused into the patient The adoptive cell therapy is further enhanced through the use of non-myeloablative chemotherapy prior to TIL infusion followed by the TIL plus IL-2 infusion Low-dose radiation therapy is administered prior to and after TIL plus IL-2 infusion Pembrolizumab is provided after the resolution of IL-2 toxicities The trial is open to solid tumors of varying tumor mutational burdens
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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