NCT06954558

A Single-Arm, Open-Label, Phase I Study of GK01 for Advanced Solid Tumor

The Phase I, Open-label, Single-arm Clinical Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase I, open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	GK01 Injection	Autologous tumor-reactive T cells injection

Timeline

• Start date: 2025-03-18
• Primary completion: 2028-03-18
• Completion: 2028-07-18
• First posted: 2025-05-01
• Last updated: 2025-05-01

Locations

1 site across 1 country: China