NCT06144671

GT201 Injection For The Treatment Of Advanced Solid Tumors

A Single-Arm Phase I/II Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT201) for The Treatment Of Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Grit Biotechnology · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Expected to complete 7 to 18 evaluable subjects (patients with advanced solid tumors)，3 dose groups.A modified "3+3" dose-escalation design is utilized,This includes both accelerated dose escalation and traditional "3+3" dose escalation.The first dose group is accelerated titration,The first dose group is an accelerated titration of 1 to 6 evaluable subjects;The second and third dose groups are based on the traditional "3+3" dose-escalation principle,The second and third dose groups are based on the traditional "3+3" dose-escalation principle, with 3 to 6 evaluable subjects enrolled respectively.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	GT201	Autologous tumor infiltrating lymphocyte injection

Timeline

• Start date: 2023-09-13
• Primary completion: 2026-09-13
• Completion: 2026-09-13
• First posted: 2023-11-22
• Last updated: 2023-12-20

Locations

4 sites across 1 country: China