NCT07378436

A Clinical Study of GK02 in Malignant Ascites

A Single-Arm, Single-Center, Open-Label Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Autologous Tumor-Reactive T Cells(GK02) Derived From Malignant Ascites Caused by Advanced Solid Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Beijing Geekgene Technology Co., LTD · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A single-arm, single-center, open-label clinical study comprising three cohorts, evaluating the safety, preliminary efficacy, and pharmacokinetic/ pharmacodynamic (PK/PD) characteristics of autologous tumor-reactive T cells (GK02) derived from malignant ascites caused by advanced solid tumors. The trial initially plans to enroll 9 subjects with malignant ascites caused by advanced solid tumors.

Detailed description

To evaluate the safety and preliminary efficacy of an investigational cell therapy, Autologous Tumor-reactive T Cells (GK02) derived from malignant ascites caused by advanced solid tumors. Following intraperitoneal infusion of GK02, the safety and tolerability of the subjects will be observed, the preliminary effectiveness of the investigational product GK02 in treating malignant ascites will be evaluated, and the pharmacokinetic/pharmacodynamic (PK/PD) characteristics post-administration will be exploratively assessed.

Conditions

• Malignant Ascites Caused by Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	GK02	Autologous tumor-reactive T cells

Timeline

• Start date: 2025-09-16
• Primary completion: 2026-12-17
• Completion: 2027-12-17
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

1 site across 1 country: China