Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:21 AM
Study NCT ID:
NCT07349160
Status:
RECRUITING
Last Update Posted:
2026-01-16
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) for the Treatment of Advanced Solid Tumors
Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
Safety and Efficacy of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) for the Treatment of Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-11
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:
A Study of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) Therapy for Patients With Advanced Solid Tumors
Detailed Description:
This is an open-label study. This study is indicated for advanced solid tumors. The selections of dose levels and the number of subjects are based on clinical trials of similar products and the outcomes of our preliminary clinical studies.
1. Main research objectives:
To evaluate the safety of metabolically armed tumor-infiltrating lymphocytes (TILs) in patients with advanced solid tumors.
2. Secondary research objectives:
(1)To evaluate the objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and disease control rate (DCR) of metabolically armed tumor-infiltrating lymphocytes (Meta10-TIL) with RECIST v1.1; (2)To evaluate the overall survival (OS); (3) Characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of Meta10-TILs.
1. Main research objectives:
To evaluate the safety of metabolically armed tumor-infiltrating lymphocytes (TILs) in patients with advanced solid tumors.
2. Secondary research objectives:
(1)To evaluate the objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and disease control rate (DCR) of metabolically armed tumor-infiltrating lymphocytes (Meta10-TIL) with RECIST v1.1; (2)To evaluate the overall survival (OS); (3) Characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of Meta10-TILs.
Study Oversight
Has Oversight DMC:
False
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?: