RecruitingEarly Phase 1NCT07378436

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


Sponsor

Beijing Geekgene Technology Co., LTD

Enrollment

9 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the safety and effectiveness of GK02, an experimental drug, for treating malignant ascites — a buildup of fluid in the abdomen caused by advanced cancer that has not responded to at least two prior treatments. **You may be eligible if...** - You are 18–75 years old with confirmed advanced solid tumors (such as gastric, colorectal, pancreatic, or ovarian cancer) that have not responded to at least two prior treatments - You have been diagnosed with malignant ascites and your doctor believes treatment is needed - Your abdomen fluid level is confirmed to be at least moderate by ultrasound - Your overall health status is adequate (ECOG 0–2) - Your organ function is within acceptable ranges **You may NOT be eligible if...** - You have had a severe allergic reaction to a similar drug - You have received recent treatment for the ascites in the past 14 days - You are pregnant or breastfeeding - You have conditions that make abdominal puncture unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGK02

Autologous tumor-reactive T cells


Locations(1)

Beijing GoBroad Hospital

Beijing, China

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NCT07378436