NCT07351903

A Single-arm, Open-label Study of GK01 in Combination With or Without Chemotherapy for the Adjuvant Treatment of Solid Tumors

The Single-arm Open-label Clinical Study Evaluating the Use of GK01 Cell Injection in Combination With or Without Chemotherapy for the Adjuvant Treatment of 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 an open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.

Conditions

• Solid Tumors

Interventions

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

Timeline

• Start date: 2025-10-16
• Primary completion: 2028-10-15
• Completion: 2029-02-14
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: China