NCT07106814

Safety and Efficacy of Metabolically Armed Tumor-lnfiltrating Lymphocytes (Meta10-TIL) for the Treatment of Advanced Solid Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Metabolically Armed TIL cells	Each subject receive metabolically armed TIL cells by intravenous infusion.

Timeline

• Start date: 2025-08-29
• Primary completion: 2027-08-15
• Completion: 2027-12-30
• First posted: 2025-08-06
• Last updated: 2025-09-15

Locations

1 site across 1 country: China